Lupus Erythematosus, Systemic
Conditions
Keywords
Autoimmunity, Immune System Disorders
Brief summary
The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based self-management education program that has been shown to help people with chronic conditions to take control of their health problems. This study focuses on African American women with SLE because the CDSMP has not been widely studied in this population.
Detailed description
The CDSMP is an evidence-based, community-based, generic self-management program that consists of 6 weekly classes of two and a half hours each one, for six weeks. CDSMP classes are facilitated by certified peer leaders. Because the CDSMP is widely disseminated and available to the adult U.S. population through community centers, it may be a suitable and accessible option for African Americans with SLE, even though it is not specifically tailored to SLE or to African Americans. As the CDSMP has been primarily evaluated in predominantly white middle-class seniors with more common diseases (e.g. osteoarthritis, diabetes), the effectiveness of the CDSMP in helping African American women to self-manage SLE is unknown. This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with lupus. Using a two-group longitudinal cohort design with participants sampled from a parent population-based SLE cohort in Georgia, investigators will examine behaviors, health and healthcare outcomes, and the extent to which individual characteristics modify the effectiveness of the CDSMP. The Georgians Organized Against Lupus (GOAL), a longitudinal cohort of patients with a validated diagnosis of SLE, will be used to enroll participants into the intervention. A random sample of African American women with SLE selected from the parent GOAL cohort will be recruited into the WELL (Women Empowered to Live with Lupus) cohort. WELL participants will attend the CDSMP classes in the community, along with people with other chronic illnesses. WELL participants will be asked to attend the CDSMP in the community and answer questionnaires at 4 select time periods before and after the program. Investigators will follow participant's progress for up to 18 months after they attend the CDSMP. African American women from the GOAL cohort non-selected to be assigned to the intervention will comprise the usual care group. Participants will continue their longitudinal assessments as part of the GOAL cohort data collection efforts. Changes in outcomes for up to 18 months will be compared between WELL participants and the usual care group.
Interventions
The CDSMP consists of 6 weekly classes of two and a half hours each one, for six weeks. A group of 10-16 people with different chronic conditions attend the classes together. Classes are facilitated by two certified leaders, one or both of whom are non-health professionals with chronic diseases. The workshop covers topics such as: 1) how to deal with frustration, fatigue, pain and isolation, 2) exercise for maintaining and improving strength, flexibility, and endurance, 3) communicating effectively with family, friends, and health professionals, 4) nutrition, 5) decision making, 6) appropriate use of medications and how to evaluate new treatments. Participants receive a companion book, Living a Healthy Life with Chronic Conditions, and an audio relaxation CD, Relaxation for Mind and Body.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Centers for Disease Control and Prevention
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently participating in the GOAL study
Exclusion criteria
* Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years * Significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Anxiety Score | Baseline, Months 6, 12, and 18 | The PROMIS Anxiety SF 8a is a self-administered instrument to assess emotional distress within the past seven days. Participants are asked to rate their anxiety level for various items ranked from 1 to 5, where 1 represents never and 5 represents always. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates high anxiety; scores higher than 50 indicate greater anxiety compared to the reference population. |
| Communication With Physician - Stanford 3Q Scale Score | Baseline, Months 6, 12, and 18 | The Stanford 3Q Scale is a three-question measure that assesses communication between patients and physicians. The participant is asked to rank their responses using a 5-point Likert scale. Total scores range fro 0 to 5 and a higher score indicates better communication with physicians. |
| Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Baseline, Months 6, 12, and 18 | Self-efficacy for managing medical care was assessed with the PROMIS Self-efficacy for Managing Medications and Treatments Short Form (SF) 8a instrument. This is an eight-item tool that quantifies the level of current confidence (from 1=not confident at all to 5=very confident) a person with a chronic condition has in taking and managing medication and other treatments in challenging situations (e.g., traveling, running out of medication, occurrence of side effects). Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score indicates better self-efficacy for managing medications and treatments; scores higher than 50 indicate greater self-efficacy for managing medical care compared to the reference population. |
| PROMIS Global Health Physical Health Domain Score | Baseline, Months 6, 12, and 18 | The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical health; scores higher than 50 indicate greater physical health compared to the reference population.. |
| PROMIS Global Health Mental Health Domain Score | Baseline, Months 6, 12, and 18 | The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better mental health; scores higher than 50 indicate better mental health compared to the reference population. |
| PROMIS Physical Function Score | Baseline, Months 6, 12, 18 | The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function SF 10b is a self-administered instrument that assesses self-reported capability rather than actual performance of physical activities. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents unable to do and 5 represents without any difficulty. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical function capabilities; scores higher than 50 indicate greater physical function compared to the reference population. |
| PROMIS Pain Interference Score | Baseline, Months 6, 12, and 18 | The PROMIS Pain Interference SF 8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents not at all and 5 represents very much. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A lower score indicates the least amount of pain interference; scores higher than 50 indicate greater pain interference compared to the reference population. |
| PROMIS Fatigue Score | Baseline, Months 6, 12, and 18 | The PROMIS Fatigue SF 8a is a self-administered instrument that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents never and five represents always. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10; scores higher than 50 indicate greater fatigue compared to the reference population. |
| PROMIS Sleep Disturbance Score | Baseline, Months 6, 12, and 18 | The PROMIS Sleep Disturbance SF 8a is a self-administered instrument to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It assesses sleep disturbance over the past seven days. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more sleep disturbance; scores higher than 50 indicate greater sleep disturbance compared to the reference population. |
| PROMIS Ability to Participate in Social Roles and Activities Score | Baseline, Months 6, 12, 18 | The PROMIS Ability to Participate in Social Roles and Activities SF 8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better perceived abilities; scores higher than 50 indicate better perceived abilities to participate in social activities and roles compared to the reference population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline, Months 6, 12, and 18 | The Patient Activation Measure (PAM-10) is a 10-item tool to assess an individual's knowledge, skill, and confidence for managing one's health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so. The PAM-10 survey measures individuals activation on a 0-100 scale, which are further grouped in 4 levels of activation along an empirically derived continuum. Activation Level 1 is Disengaged & Overwhelmed where knowledge of and adherence to healthcare and is low. Activation Level 2 is Becoming Aware But Still Struggling where individuals can set simple goals but believe health is out of their control. Activation Level 3 is Taking Action & Gaining Control where individuals are building self-management skills. Activation Level 4 is Maintaining Behaviors & Pushing Further where individuals are maintaining newly adopted behaviors. |
| PROMIS Adult Self-Efficacy Score | Baseline, Months 6, 12, and 18 | The PROMIS Adult Self-Efficacy SF 4a is a self-administered instrument to assess current level of confidence in managing symptoms of chronic conditions. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates higher self-efficacy; scores higher than 50 indicate greater self-efficacy compared to the reference population. |
| PROMIS Anger Score | Baseline, Months 6, 12, and 18 | The PROMIS Anger SF 5a is a self-administered instrument to measure angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more anger; scores higher than 50 indicate greater anger compared to the reference population. |
| Perceived Stress Scale 4 (PSS-4) Score | Baseline, Months 6, 12, and 18 | The Perceived Stress Scale 4 (PSS-4) is the most widely used psychological instrument for measuring the perception of stress. Participants are asked to rank responses to each of the four items on a scale from 0 to 4, where zero means never and four means very often. Total scores range from 0 to 16 and a higher score indicates higher perceived stress. |
| Hospitalization Rate | One year before and one year after the start of the study intervention (up to 2 years) | The number of hospitalizations were collected from the Georgia Department of Public Health (DPH) administrative data for the pre- and post-intervention period (up to two years). The hospitalization rate is the hospitalizations per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class. |
| Emergency Department Visit Rate | One year before and one year after the start of the study intervention (up to 2 years) | The number of emergency department (ED) visits were collected from the Georgia DPH administrative data for the pre- and post-intervention period (up to two years). The emergency department visit rate is the emergency department visits per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through Emory University in Atlanta, Georgia, USA. Participant enrollment began January 19, 2017 and the 18-month follow-up assessments were completed by February 26, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Chronic Disease Self-management Program (CDSMP) A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort. | 168 |
| Usual Care African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts. | 531 |
| Total | 699 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 18 |
| Overall Study | Lost to Follow-up | 0 | 33 |
| Overall Study | Unable to complete the 18-month survey | 1 | 27 |
| Overall Study | Withdrawal by Subject | 0 | 6 |
Baseline characteristics
| Characteristic | Chronic Disease Self-management Program (CDSMP) | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 58 Participants | 75 Participants |
| Age, Categorical Between 18 and 65 years | 151 Participants | 473 Participants | 624 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 12.3 | 47.3 years STANDARD_DEVIATION 14 | 47.9 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 531 Participants | 699 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 | 168 Participants | 531 Participants | 699 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 168 Participants | 531 Participants | 699 Participants |
| Sex: Female, Male Female | 168 Participants | 531 Participants | 699 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 168 | 18 / 531 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Communication With Physician - Stanford 3Q Scale Score
The Stanford 3Q Scale is a three-question measure that assesses communication between patients and physicians. The participant is asked to rank their responses using a 5-point Likert scale. Total scores range fro 0 to 5 and a higher score indicates better communication with physicians.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Communication With Physician - Stanford 3Q Scale Score | Month 6 | 3.3 score on a scale | Standard Deviation 1.2 |
| Chronic Disease Self-management Program (CDSMP) | Communication With Physician - Stanford 3Q Scale Score | Baseline | 3.1 score on a scale | Standard Deviation 1.1 |
| Chronic Disease Self-management Program (CDSMP) | Communication With Physician - Stanford 3Q Scale Score | Month 18 | 3.3 score on a scale | Standard Deviation 1.1 |
| Chronic Disease Self-management Program (CDSMP) | Communication With Physician - Stanford 3Q Scale Score | Month 12 | 3.3 score on a scale | Standard Deviation 1.1 |
| Usual Care | Communication With Physician - Stanford 3Q Scale Score | Month 18 | 3.0 score on a scale | Standard Deviation 1.1 |
| Usual Care | Communication With Physician - Stanford 3Q Scale Score | Baseline | 2.9 score on a scale | Standard Deviation 1.1 |
| Usual Care | Communication With Physician - Stanford 3Q Scale Score | Month 12 | 3.0 score on a scale | Standard Deviation 1.1 |
| Usual Care | Communication With Physician - Stanford 3Q Scale Score | Month 6 | 3.0 score on a scale | Standard Deviation 1.1 |
Primary
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Self-efficacy for managing medical care was assessed with the PROMIS Self-efficacy for Managing Medications and Treatments Short Form (SF) 8a instrument. This is an eight-item tool that quantifies the level of current confidence (from 1=not confident at all to 5=very confident) a person with a chronic condition has in taking and managing medication and other treatments in challenging situations (e.g., traveling, running out of medication, occurrence of side effects). Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score indicates better self-efficacy for managing medications and treatments; scores higher than 50 indicate greater self-efficacy for managing medical care compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Baseline | 46.1 T-score | Standard Deviation 9.1 |
| Chronic Disease Self-management Program (CDSMP) | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 6 | 47.0 T-score | Standard Deviation 9 |
| Chronic Disease Self-management Program (CDSMP) | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 12 | 46.2 T-score | Standard Deviation 8.8 |
| Chronic Disease Self-management Program (CDSMP) | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 18 | 45.9 T-score | Standard Deviation 8.7 |
| Usual Care | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 18 | 48.3 T-score | Standard Deviation 9.2 |
| Usual Care | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Baseline | 46.1 T-score | Standard Deviation 9.2 |
| Usual Care | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 12 | 47.0 T-score | Standard Deviation 8.9 |
| Usual Care | Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score | Month 6 | 47.5 T-score | Standard Deviation 8.5 |
Primary
PROMIS Ability to Participate in Social Roles and Activities Score
The PROMIS Ability to Participate in Social Roles and Activities SF 8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better perceived abilities; scores higher than 50 indicate better perceived abilities to participate in social activities and roles compared to the reference population.
Time frame: Baseline, Months 6, 12, 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Ability to Participate in Social Roles and Activities Score | Baseline | 45.3 T-score | Standard Deviation 8.3 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Ability to Participate in Social Roles and Activities Score | Month 6 | 45.0 T-score | Standard Deviation 8.7 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Ability to Participate in Social Roles and Activities Score | Month 12 | 45.5 T-score | Standard Deviation 8.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Ability to Participate in Social Roles and Activities Score | Month 18 | 45.5 T-score | Standard Deviation 8.1 |
| Usual Care | PROMIS Ability to Participate in Social Roles and Activities Score | Month 18 | 47.0 T-score | Standard Deviation 9.6 |
| Usual Care | PROMIS Ability to Participate in Social Roles and Activities Score | Baseline | 47.4 T-score | Standard Deviation 10.1 |
| Usual Care | PROMIS Ability to Participate in Social Roles and Activities Score | Month 12 | 46.6 T-score | Standard Deviation 10 |
| Usual Care | PROMIS Ability to Participate in Social Roles and Activities Score | Month 6 | 47.1 T-score | Standard Deviation 10.2 |
Primary
PROMIS Anxiety Score
The PROMIS Anxiety SF 8a is a self-administered instrument to assess emotional distress within the past seven days. Participants are asked to rate their anxiety level for various items ranked from 1 to 5, where 1 represents never and 5 represents always. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates high anxiety; scores higher than 50 indicate greater anxiety compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anxiety Score | Baseline | 53.8 T-score | Standard Deviation 10.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anxiety Score | Month 6 | 54.6 T-score | Standard Deviation 10.4 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anxiety Score | Month 18 | 53.2 T-score | Standard Deviation 10.7 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anxiety Score | Month 12 | 54.3 T-score | Standard Deviation 10.6 |
| Usual Care | PROMIS Anxiety Score | Month 18 | 51.6 T-score | Standard Deviation 11.3 |
| Usual Care | PROMIS Anxiety Score | Baseline | 52.0 T-score | Standard Deviation 11.5 |
| Usual Care | PROMIS Anxiety Score | Month 6 | 50.5 T-score | Standard Deviation 11.1 |
| Usual Care | PROMIS Anxiety Score | Month 12 | 52.0 T-score | Standard Deviation 11.2 |
Primary
PROMIS Fatigue Score
The PROMIS Fatigue SF 8a is a self-administered instrument that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents never and five represents always. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10; scores higher than 50 indicate greater fatigue compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Fatigue Score | Baseline | 58.6 T-score | Standard Deviation 10.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Fatigue Score | Month 6 | 59.5 T-score | Standard Deviation 9.7 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Fatigue Score | Month 12 | 58.7 T-score | Standard Deviation 10 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Fatigue Score | Month 18 | 58.2 T-score | Standard Deviation 10.5 |
| Usual Care | PROMIS Fatigue Score | Month 18 | 57.4 T-score | Standard Deviation 11.3 |
| Usual Care | PROMIS Fatigue Score | Baseline | 57.6 T-score | Standard Deviation 11.2 |
| Usual Care | PROMIS Fatigue Score | Month 12 | 57.8 T-score | Standard Deviation 11 |
| Usual Care | PROMIS Fatigue Score | Month 6 | 57.5 T-score | Standard Deviation 11.3 |
Primary
PROMIS Global Health Mental Health Domain Score
The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better mental health; scores higher than 50 indicate better mental health compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Mental Health Domain Score | Baseline | 41.5 T-score | Standard Deviation 8.9 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Mental Health Domain Score | Month 6 | 42.4 T-score | Standard Deviation 9.1 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Mental Health Domain Score | Month 12 | 42.4 T-score | Standard Deviation 8.6 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Mental Health Domain Score | Month 18 | 42.3 T-score | Standard Deviation 7.9 |
| Usual Care | PROMIS Global Health Mental Health Domain Score | Month 18 | 43.6 T-score | Standard Deviation 9.3 |
| Usual Care | PROMIS Global Health Mental Health Domain Score | Baseline | 43.5 T-score | Standard Deviation 9.3 |
| Usual Care | PROMIS Global Health Mental Health Domain Score | Month 12 | 43.4 T-score | Standard Deviation 9.1 |
| Usual Care | PROMIS Global Health Mental Health Domain Score | Month 6 | 43.2 T-score | Standard Deviation 8.8 |
Primary
PROMIS Global Health Physical Health Domain Score
The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical health; scores higher than 50 indicate greater physical health compared to the reference population..
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Physical Health Domain Score | Baseline | 38.3 T-score | Standard Deviation 7.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Physical Health Domain Score | Month 6 | 39.0 T-score | Standard Deviation 7.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Physical Health Domain Score | Month 12 | 38.9 T-score | Standard Deviation 7.6 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Global Health Physical Health Domain Score | Month 18 | 39.1 T-score | Standard Deviation 7.5 |
| Usual Care | PROMIS Global Health Physical Health Domain Score | Month 18 | 40.3 T-score | Standard Deviation 8.8 |
| Usual Care | PROMIS Global Health Physical Health Domain Score | Baseline | 40.6 T-score | Standard Deviation 8.8 |
| Usual Care | PROMIS Global Health Physical Health Domain Score | Month 12 | 40.3 T-score | Standard Deviation 8.7 |
| Usual Care | PROMIS Global Health Physical Health Domain Score | Month 6 | 40.0 T-score | Standard Deviation 8.6 |
Primary
PROMIS Pain Interference Score
The PROMIS Pain Interference SF 8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents not at all and 5 represents very much. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A lower score indicates the least amount of pain interference; scores higher than 50 indicate greater pain interference compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Pain Interference Score | Baseline | 59.0 T-score | Standard Deviation 9.2 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Pain Interference Score | Month 6 | 59.1 T-score | Standard Deviation 9 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Pain Interference Score | Month 12 | 59.3 T-score | Standard Deviation 8.7 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Pain Interference Score | Month 18 | 59.3 T-score | Standard Deviation 8.6 |
| Usual Care | PROMIS Pain Interference Score | Month 18 | 58.1 T-score | Standard Deviation 10.1 |
| Usual Care | PROMIS Pain Interference Score | Baseline | 57.7 T-score | Standard Deviation 10.1 |
| Usual Care | PROMIS Pain Interference Score | Month 12 | 57.9 T-score | Standard Deviation 10.7 |
| Usual Care | PROMIS Pain Interference Score | Month 6 | 57.6 T-score | Standard Deviation 10 |
Primary
PROMIS Physical Function Score
The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function SF 10b is a self-administered instrument that assesses self-reported capability rather than actual performance of physical activities. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents unable to do and 5 represents without any difficulty. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical function capabilities; scores higher than 50 indicate greater physical function compared to the reference population.
Time frame: Baseline, Months 6, 12, 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Physical Function Score | Month 12 | 39.0 T-score | Standard Deviation 8.4 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Physical Function Score | Month 18 | 38.4 T-score | Standard Deviation 7.5 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Physical Function Score | Baseline | 38.4 T-score | Standard Deviation 7.6 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Physical Function Score | Month 6 | 38.4 T-score | Standard Deviation 7.6 |
| Usual Care | PROMIS Physical Function Score | Month 6 | 40.8 T-score | Standard Deviation 9.8 |
| Usual Care | PROMIS Physical Function Score | Month 12 | 40.1 T-score | Standard Deviation 9.9 |
| Usual Care | PROMIS Physical Function Score | Baseline | 40.5 T-score | Standard Deviation 10 |
| Usual Care | PROMIS Physical Function Score | Month 18 | 40.4 T-score | Standard Deviation 9.8 |
Primary
PROMIS Sleep Disturbance Score
The PROMIS Sleep Disturbance SF 8a is a self-administered instrument to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It assesses sleep disturbance over the past seven days. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more sleep disturbance; scores higher than 50 indicate greater sleep disturbance compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Sleep Disturbance Score | Baseline | 57.3 T-score | Standard Deviation 10.8 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Sleep Disturbance Score | Month 6 | 57.8 T-score | Standard Deviation 10 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Sleep Disturbance Score | Month 12 | 57.3 T-score | Standard Deviation 10.3 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Sleep Disturbance Score | Month 18 | 57.7 T-score | Standard Deviation 9.8 |
| Usual Care | PROMIS Sleep Disturbance Score | Month 18 | 55.0 T-score | Standard Deviation 9 |
| Usual Care | PROMIS Sleep Disturbance Score | Baseline | 56.6 T-score | Standard Deviation 10.8 |
| Usual Care | PROMIS Sleep Disturbance Score | Month 12 | 56.5 T-score | Standard Deviation 10.1 |
| Usual Care | PROMIS Sleep Disturbance Score | Month 6 | 55.8 T-score | Standard Deviation 10.1 |
Secondary
Emergency Department Visit Rate
The number of emergency department (ED) visits were collected from the Georgia DPH administrative data for the pre- and post-intervention period (up to two years). The emergency department visit rate is the emergency department visits per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class.
Time frame: One year before and one year after the start of the study intervention (up to 2 years)
Population: This analysis includes participants with data available with the Georgia Department of Public Health.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Emergency Department Visit Rate | During the year before the start of the study intervention | 126.2 ED visits per 100 person years |
| Chronic Disease Self-management Program (CDSMP) | Emergency Department Visit Rate | During the year after the start of the study intervention | 103.9 ED visits per 100 person years |
| Usual Care | Emergency Department Visit Rate | During the year before the start of the study intervention | 121.3 ED visits per 100 person years |
| Usual Care | Emergency Department Visit Rate | During the year after the start of the study intervention | 111.5 ED visits per 100 person years |
Secondary
Hospitalization Rate
The number of hospitalizations were collected from the Georgia Department of Public Health (DPH) administrative data for the pre- and post-intervention period (up to two years). The hospitalization rate is the hospitalizations per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class.
Time frame: One year before and one year after the start of the study intervention (up to 2 years)
Population: This analysis includes participants with data available with the Georgia Department of Public Health.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Hospitalization Rate | During the year before the start of the study intervention | 42.3 hospitalizations per 100 person years |
| Chronic Disease Self-management Program (CDSMP) | Hospitalization Rate | During the year after the start of the study intervention | 49.6 hospitalizations per 100 person years |
| Usual Care | Hospitalization Rate | During the year before the start of the study intervention | 45.5 hospitalizations per 100 person years |
| Usual Care | Hospitalization Rate | During the year after the start of the study intervention | 47.8 hospitalizations per 100 person years |
Secondary
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
The Patient Activation Measure (PAM-10) is a 10-item tool to assess an individual's knowledge, skill, and confidence for managing one's health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so. The PAM-10 survey measures individuals activation on a 0-100 scale, which are further grouped in 4 levels of activation along an empirically derived continuum. Activation Level 1 is Disengaged & Overwhelmed where knowledge of and adherence to healthcare and is low. Activation Level 2 is Becoming Aware But Still Struggling where individuals can set simple goals but believe health is out of their control. Activation Level 3 is Taking Action & Gaining Control where individuals are building self-management skills. Activation Level 4 is Maintaining Behaviors & Pushing Further where individuals are maintaining newly adopted behaviors.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 1: Disengaged & Overwhelmed | 12 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 2: Becoming Aware But Still Struggling | 25 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 3: Taking Action & Gaining Control | 72 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 4: Maintaining Behaviors & Pushing Further | 56 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 1: Disengaged & Overwhelmed | 13 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 2: Becoming Aware But Still Struggling | 26 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 3: Taking Action & Gaining Control | 56 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 4: Maintaining Behaviors & Pushing Further | 59 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 1: Disengaged & Overwhelmed | 8 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 2: Becoming Aware But Still Struggling | 13 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 3: Taking Action & Gaining Control | 70 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 4: Maintaining Behaviors & Pushing Further | 63 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 1: Disengaged & Overwhelmed | 14 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 2: Becoming Aware But Still Struggling | 30 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 3: Taking Action & Gaining Control | 58 Participants |
| Chronic Disease Self-management Program (CDSMP) | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 4: Maintaining Behaviors & Pushing Further | 62 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 4: Maintaining Behaviors & Pushing Further | 162 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 1: Disengaged & Overwhelmed | 40 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 1: Disengaged & Overwhelmed | 26 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 2: Becoming Aware But Still Struggling | 123 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 1: Disengaged & Overwhelmed | 33 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 3: Taking Action & Gaining Control | 206 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 2: Becoming Aware But Still Struggling | 73 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Baseline | Level 4: Maintaining Behaviors & Pushing Further | 154 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 3: Taking Action & Gaining Control | 161 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 1: Disengaged & Overwhelmed | 25 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 3: Taking Action & Gaining Control | 154 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 2: Becoming Aware But Still Struggling | 44 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 18 | Level 2: Becoming Aware But Still Struggling | 80 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 3: Taking Action & Gaining Control | 101 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 12 | Level 4: Maintaining Behaviors & Pushing Further | 113 Participants |
| Usual Care | Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) | Month 6 | Level 4: Maintaining Behaviors & Pushing Further | 90 Participants |
Secondary
Perceived Stress Scale 4 (PSS-4) Score
The Perceived Stress Scale 4 (PSS-4) is the most widely used psychological instrument for measuring the perception of stress. Participants are asked to rank responses to each of the four items on a scale from 0 to 4, where zero means never and four means very often. Total scores range from 0 to 16 and a higher score indicates higher perceived stress.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Perceived Stress Scale 4 (PSS-4) Score | Baseline | 6.2 score on a scale | Standard Deviation 3.2 |
| Chronic Disease Self-management Program (CDSMP) | Perceived Stress Scale 4 (PSS-4) Score | Month 12 | 6.0 score on a scale | Standard Deviation 3.3 |
| Chronic Disease Self-management Program (CDSMP) | Perceived Stress Scale 4 (PSS-4) Score | Month 6 | 6.2 score on a scale | Standard Deviation 3.3 |
| Chronic Disease Self-management Program (CDSMP) | Perceived Stress Scale 4 (PSS-4) Score | Month 18 | 6.1 score on a scale | Standard Deviation 3.2 |
| Usual Care | Perceived Stress Scale 4 (PSS-4) Score | Month 18 | 6.1 score on a scale | Standard Deviation 3.1 |
| Usual Care | Perceived Stress Scale 4 (PSS-4) Score | Baseline | 6.3 score on a scale | Standard Deviation 3.2 |
| Usual Care | Perceived Stress Scale 4 (PSS-4) Score | Month 6 | 6.1 score on a scale | Standard Deviation 3.2 |
| Usual Care | Perceived Stress Scale 4 (PSS-4) Score | Month 12 | 6.4 score on a scale | Standard Deviation 3.1 |
Secondary
PROMIS Adult Self-Efficacy Score
The PROMIS Adult Self-Efficacy SF 4a is a self-administered instrument to assess current level of confidence in managing symptoms of chronic conditions. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates higher self-efficacy; scores higher than 50 indicate greater self-efficacy compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Adult Self-Efficacy Score | Baseline | 47.1 T-score | Standard Deviation 7.8 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Adult Self-Efficacy Score | Month 6 | 47.5 T-score | Standard Deviation 7.8 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Adult Self-Efficacy Score | Month 18 | 48.2 T-score | Standard Deviation 7.8 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Adult Self-Efficacy Score | Month 12 | 48.2 T-score | Standard Deviation 8.5 |
| Usual Care | PROMIS Adult Self-Efficacy Score | Month 18 | 49.3 T-score | Standard Deviation 8.8 |
| Usual Care | PROMIS Adult Self-Efficacy Score | Baseline | 48.4 T-score | Standard Deviation 8.7 |
| Usual Care | PROMIS Adult Self-Efficacy Score | Month 6 | 49.1 T-score | Standard Deviation 9 |
| Usual Care | PROMIS Adult Self-Efficacy Score | Month 12 | 48.7 T-score | Standard Deviation 8.6 |
Secondary
PROMIS Anger Score
The PROMIS Anger SF 5a is a self-administered instrument to measure angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more anger; scores higher than 50 indicate greater anger compared to the reference population.
Time frame: Baseline, Months 6, 12, and 18
Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anger Score | Baseline | 53.2 T-score | Standard Deviation 11.6 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anger Score | Month 6 | 53.5 T-score | Standard Deviation 13 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anger Score | Month 12 | 52.7 T-score | Standard Deviation 11.8 |
| Chronic Disease Self-management Program (CDSMP) | PROMIS Anger Score | Month 18 | 52.3 T-score | Standard Deviation 12.3 |
| Usual Care | PROMIS Anger Score | Month 18 | 50.9 T-score | Standard Deviation 12.6 |
| Usual Care | PROMIS Anger Score | Baseline | 51.0 T-score | Standard Deviation 12.4 |
| Usual Care | PROMIS Anger Score | Month 12 | 50.8 T-score | Standard Deviation 12.3 |
| Usual Care | PROMIS Anger Score | Month 6 | 50.3 T-score | Standard Deviation 12.5 |