Chronic Medical Illness, Mental Illness
Conditions
Keywords
self-management
Brief summary
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.
Detailed description
Background: Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care. Aims: Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well intervention with 242 Veterans with mental illness and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. The investigators hypothesize that those randomized to the Living Well intervention will, in comparison to those randomized to a medical illness education and support group, demonstrate improved general health functioning including physical and emotional functioning as well as reduced rates of medical emergency room visits for management of a chronic medical condition. The investigators will also evaluate intervention effects on more proximal attitudinal and behavioral outcomes and assess how these factors mediate improvement in the functional and services related outcomes. Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation framework to better understand contextual factors that can improve the Reach, Effectiveness, Adoption, Implementation and Maintenance which together determine the potential public health impact of the Living Well intervention. Methods: A mix of temporally overlapping quantitative and qualitative methods will be used to maximize integration and synthesis of data streams across the two aims to optimize knowledge accrual. Impact: Despite the growing recognition that self-management strategies hold enormous promise for improving quality and outcomes of care for chronic medical illnesses, and the fact that self-management is gaining prominence as a mental health recovery oriented treatment focus, there are currently no evidence-based peer facilitated medical illness self-management interventions available for dissemination within the VA mental health system. The proposed study is designed to both generate evidence supporting the effectiveness of a peer co-facilitated intervention and to help speed throughput to public health impact by collecting important contextual information about factors that may improve future dissemination and implementation efforts.
Interventions
BEHAVIORALLiving Well
This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
BEHAVIORALMedical Illness Education & Support Group
The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* a diagnosis of schizophrenia/ schizoaffective disorder * bipolar disorder * major depression with psychotic features * post traumatic stress disorder * or psychosis not otherwise specified (NOS) * age between 18 and 80 * chart documented presence of at least one of the following chronic medical conditions: * a respiratory condition (e.g. asthma, COPD) * diabetes * arthritis * cardiovascular condition (e.g. congestive heart failure, hypertension, etc.) * receiving mental health services at a designated study site * willing and able to provide consent to participate * deemed clinically stable enough to participate in the study by a treatment provider
Exclusion criteria
* Severe or profound mental retardation * Because participants must be able to attend the intervention if assigned to either condition, we will also require potential participants to verify their availability during screening * Participation in current ongoing study 'Reducing Internalized Stigma in People with Serious Mental Illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 (SF-12) General Health (Norm Based) | Baseline, Post-intervention (3 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline, Post-intervention (3 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline, Post-intervention (3 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| ER Visit Between Baseline and the 6-month Follow-up | Baseline, Follow-up (6-months after baseline) | Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management. |
| Measure of Self-Management Behaviors - Accessing Social Support Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior. |
| Measure of Self-Management Behaviors - Physical Activity Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior. |
| Measure of Self-Management Behaviors - Healthy Eating Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior. |
| Short Form-12 (SF-12) General Health (Norm Based) | Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline) | 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness. |
| Illness Management Self-Efficacy | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency. |
| Patient Activation Measure | Baseline, Post-intervention (3 months after baseline) | This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity. |
| Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior. |
| Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Baseline, Post-intervention (3 months after baseline) | This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Morisky Medication Adherence Scale | Baseline, Post-intervention (3 months after baseline) | This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis. |
| Multidimensional Health Locus of Control (HLOC) | Baseline, Post-intervention (3 months after baseline) | Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health. |
| Maryland Assessment of Recovery Scale (MARS) | Baseline, Post-intervention (3 months after baseline) | The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. |
Countries
United States
Participant flow
Pre-assignment details
262 participants were enrolled in the study prior to randomization. 20 participants were not able to be randomized due to attrition resulting in a final study sample of 242.
Participants by arm
| Arm | Count |
|---|---|
| Living Well Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months. | 124 |
| Medical Illness Education and Support Group The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion. | 118 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 9 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Medical Illness Education and Support Group | Total | Living Well |
|---|---|---|---|
| Age, Continuous | 57.0 years STANDARD_DEVIATION 7.8 | 57.8 years STANDARD_DEVIATION 7.7 | 58.5 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 235 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 151 Participants | 82 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 69 Participants | 31 Participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 103 Participants | 210 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 118 |
| other Total, other adverse events | 39 / 124 | 30 / 118 |
| serious Total, serious adverse events | 0 / 124 | 0 / 118 |
Outcome results
Primary
ER Visit Between Baseline and the 6-month Follow-up
Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Time frame: Baseline, Follow-up (6-months after baseline)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Living Well | ER Visit Between Baseline and the 6-month Follow-up | Baseline | 49 Participants |
| Living Well | ER Visit Between Baseline and the 6-month Follow-up | 6 month follow-up | 47 Participants |
| Medical Illness Education and Support Group | ER Visit Between Baseline and the 6-month Follow-up | 6 month follow-up | 48 Participants |
| Medical Illness Education and Support Group | ER Visit Between Baseline and the 6-month Follow-up | Baseline | 45 Participants |
Comparison: A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.p-value: 0.64Mixed Models Analysis
Primary
Short Form-12 (SF-12) General Health (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short Form-12 (SF-12) General Health (Norm Based) | Baseline | 40.4 units on a scale | Standard Deviation 12 |
| Living Well | Short Form-12 (SF-12) General Health (Norm Based) | Post-intervention | 42.5 units on a scale | Standard Deviation 11.3 |
| Medical Illness Education and Support Group | Short Form-12 (SF-12) General Health (Norm Based) | Baseline | 38.9 units on a scale | Standard Deviation 12.5 |
| Medical Illness Education and Support Group | Short Form-12 (SF-12) General Health (Norm Based) | Post-intervention | 41.6 units on a scale | Standard Deviation 12.2 |
Comparison: To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.p-value: 0.362Mixed Models Analysis
Primary
Short-Form 12 (SF-12) Mental Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline | 41.3 units on a scale | Standard Deviation 11.9 |
| Living Well | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Post-intervention | 44.0 units on a scale | Standard Deviation 11.4 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline | 40.7 units on a scale | Standard Deviation 11.5 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Post-intervention | 40.5 units on a scale | Standard Deviation 11.6 |
Comparison: To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.p-value: 0.032Mixed Models Analysis
Primary
Short-Form 12 (SF-12) Physical Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline | 39.2 units on a scale | Standard Deviation 10.4 |
| Living Well | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Post-intervention | 39.0 units on a scale | Standard Deviation 10.3 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline | 38.6 units on a scale | Standard Deviation 11.4 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Post-intervention | 40.2 units on a scale | Standard Deviation 11.3 |
Comparison: To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.p-value: 0.026Mixed Models Analysis
Secondary
Illness Management Self-Efficacy
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Illness Management Self-Efficacy | Baseline | 5.5 units on a scale | Standard Deviation 2.1 |
| Living Well | Illness Management Self-Efficacy | Post-intervention | 6.2 units on a scale | Standard Deviation 1.9 |
| Medical Illness Education and Support Group | Illness Management Self-Efficacy | Baseline | 5.5 units on a scale | Standard Deviation 2 |
| Medical Illness Education and Support Group | Illness Management Self-Efficacy | Post-intervention | 5.4 units on a scale | Standard Deviation 2.1 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: <0.0001Mixed Models Analysis
Secondary
Illness Management Self-Efficacy
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Illness Management Self-Efficacy | Baseline | 5.5 units on a scale | Standard Deviation 2.1 |
| Living Well | Illness Management Self-Efficacy | Post-intervention | 6.2 units on a scale | Standard Deviation 1.9 |
| Living Well | Illness Management Self-Efficacy | Follow-up | 6.0 units on a scale | Standard Deviation 2 |
| Medical Illness Education and Support Group | Illness Management Self-Efficacy | Baseline | 5.5 units on a scale | Standard Deviation 2 |
| Medical Illness Education and Support Group | Illness Management Self-Efficacy | Post-intervention | 5.4 units on a scale | Standard Deviation 2.1 |
| Medical Illness Education and Support Group | Illness Management Self-Efficacy | Follow-up | 5.4 units on a scale | Standard Deviation 2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.004Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Accessing Social Support Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.4 |
| Living Well | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Follow-up | 2.2 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Follow-up | 2.3 units on a scale | Standard Deviation 1.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.238Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Accessing Social Support Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.4 |
| Living Well | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Accessing Social Support Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.762Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Baseline | 2.2 units on a scale | Standard Deviation 1.1 |
| Living Well | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Post-intervention | 2.5 units on a scale | Standard Deviation 1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Baseline | 2.2 units on a scale | Standard Deviation 1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Post-intervention | 2.2 units on a scale | Standard Deviation 0.9 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.006Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-Intervention, Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Baseline | 2.2 units on a scale | Standard Deviation 1.1 |
| Living Well | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Post-intervention | 2.5 units on a scale | Standard Deviation 1 |
| Living Well | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Follow-up | 2.5 units on a scale | Standard Deviation 1.1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Baseline | 2.2 units on a scale | Standard Deviation 1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Post-intervention | 2.2 units on a scale | Standard Deviation 0.9 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale | Follow-up | 2.3 units on a scale | Standard Deviation 0.9 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.038Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Baseline | 2.7 units on a scale | Standard Deviation 1.1 |
| Living Well | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Post-intervention | 2.9 units on a scale | Standard Deviation 1.2 |
| Living Well | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Follow-up | 2.9 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Post-intervention | 2.6 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Follow-up | 2.5 units on a scale | Standard Deviation 1.2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.446Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Baseline | 2.7 units on a scale | Standard Deviation 1.1 |
| Living Well | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Post-intervention | 2.9 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale | Post-intervention | 2.6 units on a scale | Standard Deviation 1.2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.544Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Healthy Eating Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Healthy Eating Subscale | Baseline | 2.6 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Healthy Eating Subscale | Post-intervention | 3.0 units on a scale | Standard Deviation 1.1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Healthy Eating Subscale | Baseline | 2.5 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Healthy Eating Subscale | Post-intervention | 2.7 units on a scale | Standard Deviation 1.1 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.667Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Healthy Eating Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Healthy Eating Subscale | Baseline | 2.6 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Healthy Eating Subscale | Post-intervention | 3.0 units on a scale | Standard Deviation 1.1 |
| Living Well | Measure of Self-Management Behaviors - Healthy Eating Subscale | Follow-up | 2.9 units on a scale | Standard Deviation 1.1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Healthy Eating Subscale | Baseline | 2.5 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Healthy Eating Subscale | Post-intervention | 2.7 units on a scale | Standard Deviation 1.1 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Healthy Eating Subscale | Follow-up | 2.8 units on a scale | Standard Deviation 1.2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.709Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Baseline | 2.9 units on a scale | Standard Deviation 1.4 |
| Living Well | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Post-intervention | 3.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Post-intervention | 2.9 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Baseline | 2.5 units on a scale | Standard Deviation 1.4 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.699Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Follow-up | 3.3 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Baseline | 2.9 units on a scale | Standard Deviation 1.4 |
| Living Well | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Post-intervention | 3.3 units on a scale | Standard Deviation 1.2 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Post-intervention | 2.9 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Baseline | 2.5 units on a scale | Standard Deviation 1.4 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale | Follow-up | 3.0 units on a scale | Standard Deviation 1.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.459Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Physical Activity Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Physical Activity Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Physical Activity Subscale | Post-intervention | 2.7 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Physical Activity Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Physical Activity Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.326Mixed Models Analysis
Secondary
Measure of Self-Management Behaviors - Physical Activity Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Measure of Self-Management Behaviors - Physical Activity Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Physical Activity Subscale | Post-intervention | 2.7 units on a scale | Standard Deviation 1.3 |
| Living Well | Measure of Self-Management Behaviors - Physical Activity Subscale | Follow-up | 2.8 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Physical Activity Subscale | Baseline | 2.3 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Physical Activity Subscale | Post-intervention | 2.4 units on a scale | Standard Deviation 1.3 |
| Medical Illness Education and Support Group | Measure of Self-Management Behaviors - Physical Activity Subscale | Follow-up | 2.2 units on a scale | Standard Deviation 1.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.011Mixed Models Analysis
Secondary
Patient Activation Measure
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Patient Activation Measure | Baseline | 60.8 units on a scale | Standard Deviation 15.2 |
| Living Well | Patient Activation Measure | Post-intervention | 64.3 units on a scale | Standard Deviation 14 |
| Living Well | Patient Activation Measure | Follow-up | 63.4 units on a scale | Standard Deviation 14.6 |
| Medical Illness Education and Support Group | Patient Activation Measure | Baseline | 58.8 units on a scale | Standard Deviation 14.6 |
| Medical Illness Education and Support Group | Patient Activation Measure | Post-intervention | 58.9 units on a scale | Standard Deviation 14.3 |
| Medical Illness Education and Support Group | Patient Activation Measure | Follow-up | 60.5 units on a scale | Standard Deviation 16.1 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.727Mixed Models Analysis
Secondary
Patient Activation Measure
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Patient Activation Measure | Baseline | 60.8 units on a scale | Standard Deviation 15.2 |
| Living Well | Patient Activation Measure | Post-intervention | 64.3 units on a scale | Standard Deviation 14 |
| Medical Illness Education and Support Group | Patient Activation Measure | Baseline | 58.8 units on a scale | Standard Deviation 14.6 |
| Medical Illness Education and Support Group | Patient Activation Measure | Post-intervention | 58.9 units on a scale | Standard Deviation 14.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.038Mixed Models Analysis
Secondary
Short Form-12 (SF-12) General Health (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short Form-12 (SF-12) General Health (Norm Based) | Baseline | 40.4 units on a scale | Standard Deviation 12 |
| Living Well | Short Form-12 (SF-12) General Health (Norm Based) | Post-intervention | 42.5 units on a scale | Standard Deviation 11.3 |
| Living Well | Short Form-12 (SF-12) General Health (Norm Based) | Follow-up | 42.9 units on a scale | Standard Deviation 12 |
| Medical Illness Education and Support Group | Short Form-12 (SF-12) General Health (Norm Based) | Baseline | 38.9 units on a scale | Standard Deviation 12.5 |
| Medical Illness Education and Support Group | Short Form-12 (SF-12) General Health (Norm Based) | Post-intervention | 41.6 units on a scale | Standard Deviation 12.2 |
| Medical Illness Education and Support Group | Short Form-12 (SF-12) General Health (Norm Based) | Follow-up | 39.2 units on a scale | Standard Deviation 12.2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.142Mixed Models Analysis
Secondary
Short-Form 12 (SF-12) Mental Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline | 41.3 units on a scale | Standard Deviation 11.9 |
| Living Well | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Post-intervention | 44.0 units on a scale | Standard Deviation 11.4 |
| Living Well | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Follow-up | 42.7 units on a scale | Standard Deviation 11.5 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Baseline | 40.7 units on a scale | Standard Deviation 11.5 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Post-intervention | 40.5 units on a scale | Standard Deviation 11.6 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Mental Scale (Norm Based) | Follow-up | 41.5 units on a scale | Standard Deviation 12.2 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.563Mixed Models Analysis
Secondary
Short-Form 12 (SF-12) Physical Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline | 39.2 units on a scale | Standard Deviation 10.4 |
| Living Well | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Post-intervention | 39.0 units on a scale | Standard Deviation 10.3 |
| Living Well | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Follow-up | 40.3 units on a scale | Standard Deviation 10.2 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Baseline | 38.6 units on a scale | Standard Deviation 11.4 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Post-intervention | 40.2 units on a scale | Standard Deviation 11.3 |
| Medical Illness Education and Support Group | Short-Form 12 (SF-12) Physical Scale (Norm Based) | Follow-up | 38.4 units on a scale | Standard Deviation 12.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.342Mixed Models Analysis
Other Pre-specified
Maryland Assessment of Recovery Scale (MARS)
The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)
Time frame: Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Maryland Assessment of Recovery Scale (MARS) | Baseline | 3.9 units on a scale | Standard Deviation 0.7 |
| Living Well | Maryland Assessment of Recovery Scale (MARS) | Post-intervention | 4.0 units on a scale | Standard Deviation 0.7 |
| Living Well | Maryland Assessment of Recovery Scale (MARS) | Follow-up | 4.0 units on a scale | Standard Deviation 0.7 |
| Medical Illness Education and Support Group | Maryland Assessment of Recovery Scale (MARS) | Baseline | 3.8 units on a scale | Standard Deviation 0.7 |
| Medical Illness Education and Support Group | Maryland Assessment of Recovery Scale (MARS) | Post-intervention | 3.8 units on a scale | Standard Deviation 0.7 |
| Medical Illness Education and Support Group | Maryland Assessment of Recovery Scale (MARS) | Follow-up | 3.8 units on a scale | Standard Deviation 0.7 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.222Mixed Models Analysis
Other Pre-specified
Maryland Assessment of Recovery Scale (MARS)
The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Maryland Assessment of Recovery Scale (MARS) | Baseline | 3.9 units on a scale | Standard Deviation 0.7 |
| Living Well | Maryland Assessment of Recovery Scale (MARS) | Post-intervention | 4.0 units on a scale | Standard Deviation 0.7 |
| Medical Illness Education and Support Group | Maryland Assessment of Recovery Scale (MARS) | Baseline | 3.8 units on a scale | Standard Deviation 0.7 |
| Medical Illness Education and Support Group | Maryland Assessment of Recovery Scale (MARS) | Post-intervention | 3.8 units on a scale | Standard Deviation 0.7 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.099Mixed Models Analysis
Other Pre-specified
Morisky Medication Adherence Scale
This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Morisky Medication Adherence Scale | Baseline | 1.4 units on a scale | Standard Deviation 1 |
| Living Well | Morisky Medication Adherence Scale | Post-intervention | 1.2 units on a scale | Standard Deviation 1 |
| Medical Illness Education and Support Group | Morisky Medication Adherence Scale | Baseline | 1.5 units on a scale | Standard Deviation 0.8 |
| Medical Illness Education and Support Group | Morisky Medication Adherence Scale | Post-intervention | 1.5 units on a scale | Standard Deviation 0.9 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.134Mixed Models Analysis
Other Pre-specified
Morisky Medication Adherence Scale
Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time frame: Baseline, Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Morisky Medication Adherence Scale | Baseline | 1.4 units on a scale | Standard Deviation 1 |
| Living Well | Morisky Medication Adherence Scale | Post-intervention | 1.2 units on a scale | Standard Deviation 1 |
| Living Well | Morisky Medication Adherence Scale | Follow-up | 1.2 units on a scale | Standard Deviation 1 |
| Medical Illness Education and Support Group | Morisky Medication Adherence Scale | Baseline | 1.5 units on a scale | Standard Deviation 0.8 |
| Medical Illness Education and Support Group | Morisky Medication Adherence Scale | Post-intervention | 1.5 units on a scale | Standard Deviation 0.9 |
| Medical Illness Education and Support Group | Morisky Medication Adherence Scale | Follow-up | 1.4 units on a scale | Standard Deviation 0.9 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.852Mixed Models Analysis
Other Pre-specified
Multidimensional Health Locus of Control (HLOC)
Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Multidimensional Health Locus of Control (HLOC) | Baseline | 26.4 units on a scale | Standard Deviation 5.9 |
| Living Well | Multidimensional Health Locus of Control (HLOC) | Post-intervention | 27.0 units on a scale | Standard Deviation 4.8 |
| Living Well | Multidimensional Health Locus of Control (HLOC) | Follow-up | 26.6 units on a scale | Standard Deviation 5.4 |
| Medical Illness Education and Support Group | Multidimensional Health Locus of Control (HLOC) | Baseline | 26.1 units on a scale | Standard Deviation 5.9 |
| Medical Illness Education and Support Group | Multidimensional Health Locus of Control (HLOC) | Post-intervention | 25.5 units on a scale | Standard Deviation 6.3 |
| Medical Illness Education and Support Group | Multidimensional Health Locus of Control (HLOC) | Follow-up | 25.7 units on a scale | Standard Deviation 5.5 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.285Mixed Models Analysis
Other Pre-specified
Multidimensional Health Locus of Control (HLOC)
Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time frame: Baseline, Post-intervention (3 months after baseline)
Population: Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living Well | Multidimensional Health Locus of Control (HLOC) | Baseline | 26.4 units on a scale | Standard Deviation 5.9 |
| Living Well | Multidimensional Health Locus of Control (HLOC) | Post-intervention | 27.0 units on a scale | Standard Deviation 4.8 |
| Medical Illness Education and Support Group | Multidimensional Health Locus of Control (HLOC) | Baseline | 26.1 units on a scale | Standard Deviation 5.9 |
| Medical Illness Education and Support Group | Multidimensional Health Locus of Control (HLOC) | Post-intervention | 25.5 units on a scale | Standard Deviation 6.3 |
Comparison: The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.p-value: 0.045Mixed Models Analysis