Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)
Conditions
Keywords
chronic disease, aging, physical function, executive function, activities of daily living, primary care
Brief summary
Conduct a pilot randomized control to assess the preliminary efficacy of IPROACTIF, an occupational therapist-delivered primary care intervention for aging and chronic disease management.
Detailed description
The IPROACTIF intervention is based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease. The 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning. This pilot randomized control trial will compare whether patients who receive IPROACTIF perform better than usual care patients on physical functioning, self-efficacy for chronic disease management, physical activity levels, executive functioning, health-related quality of life, and participation in life roles and activities.
Interventions
OTHERIPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
OTHERUsual primary care services
Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
Sponsors
National Institute on Aging (NIA)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The statistician conducting data analysis will be blinded to group assignment of study participants. A numerical code will be used to identify the study arm for each participant in the outcome database. Outcome measurement will be carried out by blinded assessors at baseline and immediately post-intervention.
Intervention model description
Participants will be randomized to receive the IPROACTIF intervention or usual primary care services. Stratified randomization will be carried out with each diagnostic category (diabetes and heart disease) serving as a stratum.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * Community-dwelling * 55 years of age * Primary diagnosis of heart disease (coronary artery disease, ischemic heart disease, hypertensive heart disease), or uncontrolled diabetes (HBA1c greater than/equal to 10) * Self-reported risk of functional decline (score of 3 or higher) on the 11-item Brief Risk Identification of Geriatric Health Tool or self-reported need for assistance with disease management
Exclusion criteria
* Current/past diagnosis of stroke or other neurological disorders * Receiving pharmacological treatment for cognition * Participating in other exercise or ADL-focused intervention studies * Non-English speaking * Residing in a long-term care institution * Compromised decision-making capacity (score \>8 on SOMCT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Functioning Measured Using the Patient-Specific Functional Scale | 12 weeks | Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points |
| Physical Functioning Measured Using the PROMIS Physical Function Short Form 20 | 12 weeks | The PROMIS Physical Function Short Form 20 (PF-20) is a measure of perceived ability to perform physical activities. Respondents rate 20 daily activities on a scale from 1 (unable to do) to 5 (no difficulty/limitation). Individual item scores are summed to compute the total raw score which is converted to a standardized T-score. T-scores range from 9.2 to 62.7. Higher T-scores indicate a better outcome. A score of 50 is the average for the United States general population with a standard deviation of 10. |
| Physical Functioning Measured Using the Physical Performance Test (9-item) | 12 weeks | 9-item performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 2.4 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale) | 12 weeks | The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the mental health sub-scale range from 21.2 to 67.6. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome. |
| Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center | 12 weeks | This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 3 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome. |
| Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center | 12 weeks | This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 5 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome. |
| Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting support from others as measured on a 4-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy |
| Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for general disease management as measured on a 5-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy |
| Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension | 12 weeks | 16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate greater frequency i.e. better performance. |
| Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting regular exercise as measured on a 3-item validated self-reported assessment; scores range from 1 to 10; higher scores indicate better self-efficacy |
| Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) as measured on the Performance Assessment of Self-care Skills (PASS). The PASS is a performance-based assessment; individual is expected to perform an ADL/IADL task which is rated on independence, safety, and adequacy. Independence scores range from 0-3; higher scores indicate better performance |
| Executive Functioning Using the Executive Function Performance Test | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) as measured on the Executive Function Performance Test (EFPT). The EFPT is a performance-based assessment; original assessment comprises three tasks; only the medication management task was used; scores range from 0-25 for this task; higher scores indicate poorer performance. |
| Executive Functioning Using the Dimensional Change Card Sort Test | 12 weeks | The NIH Toolbox Dimensional Change Card Sort (DCCS) Test is a computer-administered measure of cognitive flexibility and attention. Test takers match bivalent test pictures to the target pictures along dimensions of shape and color. Scoring is based on combining accuracy and reaction time & converted to a scale score with mean of 100 and SD of 15. Scale scores may be adjusted for age. Adjusted scores are relative to a normative sample with no universally applicable fixed minimum or maximum. Higher scores indicate better performance. Scores listed represent unadjusted scale scores. |
| Physical Activity Level | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) in the average time spent in moderate to vigorous physical activity as measured by an accelerometer worn for at least 6 hours for at least 4 days during a 7-day period. |
| Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center | 12 weeks | Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for engaging in social and recreational activities as measured on a 2-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy |
| Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension | 12 weeks | 16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance. |
| Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale) | 12 weeks | The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the physical health sub-scale range from 16.2 to 67.7. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome. |
Countries
United States
Participant flow
Pre-assignment details
45 participants were enrolled. 5 participants who enrolled dropped out/were lost to follow up before randomization to groups. Specifically, these participants began but did not complete all baseline assessments. 40 of the enrolled participants completed all baseline assessments and were assigned to the study arms as indicated in the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| IPROACTIF 10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning. | 18 |
| Usual Care Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes. | 22 |
| Total | 40 |
Baseline characteristics
| Characteristic | IPROACTIF | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 7 | 66.7 years STANDARD_DEVIATION 7.2 | 66.7 years STANDARD_DEVIATION 7.2 |
| Average time spent in moderate to vigorous physical activity (accelerometry) | 4.21 minutes | 5.04 minutes | 4.35 minutes |
| Dimensional Change Card Sort | 95 units on a scale | 95 units on a scale | 95 units on a scale |
| Doing Chores Scale from the Self-Management Resource Center | 8.15 units on a scale | 7 units on a scale | 7.85 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 20 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Executive Function Performance Test | 4.5 units on a scale | 4 units on a scale | 4 units on a scale |
| Exercise Regularly Scale from the Self-Management Resource Center | 7.15 units on a scale | 6.70 units on a scale | 6.70 units on a scale |
| Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension | 48.94 units on a scale STANDARD_DEVIATION 5.64 | 49.48 units on a scale STANDARD_DEVIATION 8.55 | 49.24 units on a scale STANDARD_DEVIATION 7.3 |
| Late Life Functioning and Disability Index (Disability Component)- Limitations Dimension | 66.26 units on a scale STANDARD_DEVIATION 10.04 | 66.62 units on a scale STANDARD_DEVIATION 16.98 | 66.46 units on a scale STANDARD_DEVIATION 14.12 |
| Manage Disease in General Scale from the Self-Management Resource Center | 8.2 units on a scale | 7.8 units on a scale | 8 units on a scale |
| Manage Symptoms Scale from the Self-Management Resource Center | 7.1 units on a scale | 6.2 units on a scale | 6.7 units on a scale |
| Obtain Help from Community, Family, Friends Scale from the Self-Management Resource Center | 7.8 units on a scale | 7 units on a scale | 7.4 units on a scale |
| Patient-Specific Functional Scale | 5.81 units on a scale STANDARD_DEVIATION 2.08 | 4.92 units on a scale STANDARD_DEVIATION 1.63 | 5.32 units on a scale STANDARD_DEVIATION 1.88 |
| Performance Assessment of Self-care Skills | 2.92 units on a scale | 3 units on a scale | 3 units on a scale |
| Physical Performance Test | 24.50 units on a scale STANDARD_DEVIATION 6.38 | 24.18 units on a scale STANDARD_DEVIATION 7.3 | 24.33 units on a scale STANDARD_DEVIATION 6.82 |
| PROMIS Global Health Measure (mental subscale) | 44.88 T-score STANDARD_DEVIATION 7.4 | 45.53 T-score STANDARD_DEVIATION 8.75 | 45.24 T-score STANDARD_DEVIATION 8.08 |
| PROMIS Global Health Measure (physical subscale) | 42.36 T-score STANDARD_DEVIATION 8.37 | 42.14 T-score STANDARD_DEVIATION 8.91 | 42.24 T-score STANDARD_DEVIATION 8.56 |
| PROMIS Physical Function Short Form 20 | 41.12 T-score STANDARD_DEVIATION 7.64 | 40.12 T-score STANDARD_DEVIATION 8.65 | 40.57 T-score STANDARD_DEVIATION 1.88 |
| 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 | 11 Participants | 14 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 18 participants | 22 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 13 Participants |
| Social Recreational Activities Scale from the Self-Management Resource Center | 7.75 units on a scale | 7.5 units on a scale | 7.5 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 1 / 18 | 0 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
Physical Functioning Measured Using the Patient-Specific Functional Scale
Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Physical Functioning Measured Using the Patient-Specific Functional Scale | 7.45 score on a scale | Standard Deviation 2.64 |
| Usual Care | Physical Functioning Measured Using the Patient-Specific Functional Scale | 5.43 score on a scale | Standard Deviation 2.31 |
p-value: 0.04ANCOVA
Primary
Physical Functioning Measured Using the Physical Performance Test (9-item)
9-item performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 2.4 points
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Physical Functioning Measured Using the Physical Performance Test (9-item) | 24.7 score on a scale | Standard Deviation 8.73 |
| Usual Care | Physical Functioning Measured Using the Physical Performance Test (9-item) | 25.4 score on a scale | Standard Deviation 6.42 |
p-value: 0.51ANCOVA
Primary
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20
The PROMIS Physical Function Short Form 20 (PF-20) is a measure of perceived ability to perform physical activities. Respondents rate 20 daily activities on a scale from 1 (unable to do) to 5 (no difficulty/limitation). Individual item scores are summed to compute the total raw score which is converted to a standardized T-score. T-scores range from 9.2 to 62.7. Higher T-scores indicate a better outcome. A score of 50 is the average for the United States general population with a standard deviation of 10.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Physical Functioning Measured Using the PROMIS Physical Function Short Form 20 | 43.91 units on a scale | Standard Deviation 12.06 |
| Usual Care | Physical Functioning Measured Using the PROMIS Physical Function Short Form 20 | 40.79 units on a scale | Standard Deviation 9.69 |
p-value: 0.26ANCOVA
Secondary
Executive Functioning Using the Dimensional Change Card Sort Test
The NIH Toolbox Dimensional Change Card Sort (DCCS) Test is a computer-administered measure of cognitive flexibility and attention. Test takers match bivalent test pictures to the target pictures along dimensions of shape and color. Scoring is based on combining accuracy and reaction time & converted to a scale score with mean of 100 and SD of 15. Scale scores may be adjusted for age. Adjusted scores are relative to a normative sample with no universally applicable fixed minimum or maximum. Higher scores indicate better performance. Scores listed represent unadjusted scale scores.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Executive Functioning Using the Dimensional Change Card Sort Test | 4.00 score on a scale |
| Usual Care | Executive Functioning Using the Dimensional Change Card Sort Test | 3.94 score on a scale |
p-value: 0.81Wilcoxon (Mann-Whitney)
Secondary
Executive Functioning Using the Executive Function Performance Test
Change from pre-test (baseline) to post-test (12 weeks) as measured on the Executive Function Performance Test (EFPT). The EFPT is a performance-based assessment; original assessment comprises three tasks; only the medication management task was used; scores range from 0-25 for this task; higher scores indicate poorer performance.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Executive Functioning Using the Executive Function Performance Test | 1.70 score on a scale |
| Usual Care | Executive Functioning Using the Executive Function Performance Test | 1.00 score on a scale |
p-value: 0.66Wilcoxon (Mann-Whitney)
Secondary
Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)
The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the mental health sub-scale range from 21.2 to 67.6. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale) | 45.71 score on a scale | Standard Deviation 8.23 |
| Usual Care | Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale) | 46.38 score on a scale | Standard Deviation 7.93 |
p-value: 0.91ANCOVA
Secondary
Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)
The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the physical health sub-scale range from 16.2 to 67.7. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale) | 48.36 score on a scale | Standard Deviation 15.9 |
| Usual Care | Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale) | 43.21 score on a scale | Standard Deviation 8.89 |
p-value: 0.22ANCOVA
Secondary
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension
16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate greater frequency i.e. better performance.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension | 52.01 score on a scale | Standard Deviation 7.02 |
| Usual Care | Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension | 50.30 score on a scale | Standard Deviation 9.39 |
p-value: 0.23ANCOVA
Secondary
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension
16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension | 74.70 score on a scale | Standard Deviation 26.17 |
| Usual Care | Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension | 70.41 score on a scale | Standard Deviation 21.03 |
p-value: 0.44ANCOVA
Secondary
Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills
Change from pre-test (baseline) to post-test (12 weeks) as measured on the Performance Assessment of Self-care Skills (PASS). The PASS is a performance-based assessment; individual is expected to perform an ADL/IADL task which is rated on independence, safety, and adequacy. Independence scores range from 0-3; higher scores indicate better performance
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills | 0.09 score on a scale |
| Usual Care | Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills | 0.00 score on a scale |
p-value: 0.65Wilcoxon (Mann-Whitney)
Secondary
Physical Activity Level
Change from pre-test (baseline) to post-test (12 weeks) in the average time spent in moderate to vigorous physical activity as measured by an accelerometer worn for at least 6 hours for at least 4 days during a 7-day period.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Physical Activity Level | -0.85 minutes |
| Usual Care | Physical Activity Level | 0.07 minutes |
p-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting regular exercise as measured on a 3-item validated self-reported assessment; scores range from 1 to 10; higher scores indicate better self-efficacy
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center | 1.02 score on a scale |
| Usual Care | Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center | 0.24 score on a scale |
p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary
Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for general disease management as measured on a 5-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center | 0.20 score on a scale |
| Usual Care | Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center | 0.00 score on a scale |
p-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting support from others as measured on a 4-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center | 0.10 score on a scale |
| Usual Care | Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center | 0.35 score on a scale |
p-value: 0.67Wilcoxon (Mann-Whitney)
Secondary
Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for engaging in social and recreational activities as measured on a 2-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IPROACTIF | Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center | 0.02 score on a scale |
| Usual Care | Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center | 0.50 score on a scale |
p-value: 0.79Wilcoxon (Mann-Whitney)
Secondary
Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center
This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 3 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center | 8.14 score on a scale | Standard Deviation 2.36 |
| Usual Care | Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center | 6.98 score on a scale | Standard Deviation 3.04 |
p-value: 0.78ANCOVA
Secondary
Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center
This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 5 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome.
Time frame: 12 weeks
Population: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPROACTIF | Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center | 7.30 score on a scale | Standard Deviation 2.05 |
| Usual Care | Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center | 7.18 score on a scale | Standard Deviation 2.21 |
p-value: 0.83ANCOVA