Trial Outcomes & Findings for Wellness Self-Management (NCT NCT01676909)
NCT ID: NCT01676909
Last Updated: 2019-06-06
Results Overview
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.
COMPLETED
NA
262 participants
Baseline, Post-intervention (3 months after baseline)
2019-06-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
118
|
|
Overall Study
Post-Treatment Assessment
|
105
|
107
|
|
Overall Study
COMPLETED
|
106
|
104
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
15
|
9
|
Baseline Characteristics
Wellness Self-Management
Baseline characteristics by cohort
| Measure |
Living Well
n=124 Participants
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.
|
Medical Illness Education and Support Group
n=118 Participants
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.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 7.6 • n=93 Participants
|
57.0 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
210 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
235 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short Form-12 (SF-12) General Health (Norm Based)
Baseline
|
38.9 units on a scale
Standard Deviation 12.5
|
40.4 units on a scale
Standard Deviation 12.0
|
|
Short Form-12 (SF-12) General Health (Norm Based)
Post-intervention
|
41.6 units on a scale
Standard Deviation 12.2
|
42.5 units on a scale
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Baseline
|
38.6 units on a scale
Standard Deviation 11.4
|
39.2 units on a scale
Standard Deviation 10.4
|
|
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Post-intervention
|
40.2 units on a scale
Standard Deviation 11.3
|
39.0 units on a scale
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Baseline
|
40.7 units on a scale
Standard Deviation 11.5
|
41.3 units on a scale
Standard Deviation 11.9
|
|
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Post-intervention
|
40.5 units on a scale
Standard Deviation 11.6
|
44.0 units on a scale
Standard Deviation 11.4
|
PRIMARY outcome
Timeframe: Baseline, Follow-up (6-months after baseline)Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
ER Visit Between Baseline and the 6-month Follow-up
Baseline
|
45 Participants
|
49 Participants
|
|
ER Visit Between Baseline and the 6-month Follow-up
6 month follow-up
|
48 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Illness Management Self-Efficacy
Baseline
|
5.5 units on a scale
Standard Deviation 2.0
|
5.5 units on a scale
Standard Deviation 2.1
|
|
Illness Management Self-Efficacy
Post-intervention
|
5.4 units on a scale
Standard Deviation 2.1
|
6.2 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Patient Activation Measure
Baseline
|
58.8 units on a scale
Standard Deviation 14.6
|
60.8 units on a scale
Standard Deviation 15.2
|
|
Patient Activation Measure
Post-intervention
|
58.9 units on a scale
Standard Deviation 14.3
|
64.3 units on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.1
|
|
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Post-intervention
|
2.6 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Baseline
|
2.5 units on a scale
Standard Deviation 1.4
|
2.9 units on a scale
Standard Deviation 1.4
|
|
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Post-intervention
|
2.9 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Baseline
|
2.2 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.1
|
|
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Post-intervention
|
2.2 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.4
|
|
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Post-intervention
|
2.4 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Physical Activity Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.3
|
2.3 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Physical Activity Subscale
Post-intervention
|
2.4 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Healthy Eating Subscale
Baseline
|
2.5 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Healthy Eating Subscale
Post-intervention
|
2.7 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short Form-12 (SF-12) General Health (Norm Based)
Baseline
|
38.9 units on a scale
Standard Deviation 12.5
|
40.4 units on a scale
Standard Deviation 12.0
|
|
Short Form-12 (SF-12) General Health (Norm Based)
Post-intervention
|
41.6 units on a scale
Standard Deviation 12.2
|
42.5 units on a scale
Standard Deviation 11.3
|
|
Short Form-12 (SF-12) General Health (Norm Based)
Follow-up
|
39.2 units on a scale
Standard Deviation 12.2
|
42.9 units on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Baseline
|
38.6 units on a scale
Standard Deviation 11.4
|
39.2 units on a scale
Standard Deviation 10.4
|
|
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Post-intervention
|
40.2 units on a scale
Standard Deviation 11.3
|
39.0 units on a scale
Standard Deviation 10.3
|
|
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Follow-up
|
38.4 units on a scale
Standard Deviation 12.3
|
40.3 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Baseline
|
40.7 units on a scale
Standard Deviation 11.5
|
41.3 units on a scale
Standard Deviation 11.9
|
|
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Post-intervention
|
40.5 units on a scale
Standard Deviation 11.6
|
44.0 units on a scale
Standard Deviation 11.4
|
|
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Follow-up
|
41.5 units on a scale
Standard Deviation 12.2
|
42.7 units on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Illness Management Self-Efficacy
Baseline
|
5.5 units on a scale
Standard Deviation 2.0
|
5.5 units on a scale
Standard Deviation 2.1
|
|
Illness Management Self-Efficacy
Post-intervention
|
5.4 units on a scale
Standard Deviation 2.1
|
6.2 units on a scale
Standard Deviation 1.9
|
|
Illness Management Self-Efficacy
Follow-up
|
5.4 units on a scale
Standard Deviation 2.0
|
6.0 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Patient Activation Measure
Baseline
|
58.8 units on a scale
Standard Deviation 14.6
|
60.8 units on a scale
Standard Deviation 15.2
|
|
Patient Activation Measure
Post-intervention
|
58.9 units on a scale
Standard Deviation 14.3
|
64.3 units on a scale
Standard Deviation 14.0
|
|
Patient Activation Measure
Follow-up
|
60.5 units on a scale
Standard Deviation 16.1
|
63.4 units on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.2
|
2.7 units on a scale
Standard Deviation 1.1
|
|
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Post-intervention
|
2.6 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
|
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Follow-up
|
2.5 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Baseline
|
2.5 units on a scale
Standard Deviation 1.4
|
2.9 units on a scale
Standard Deviation 1.4
|
|
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Post-intervention
|
2.9 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.2
|
|
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Follow-up
|
3.0 units on a scale
Standard Deviation 1.3
|
3.3 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Baseline
|
2.2 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.1
|
|
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Post-intervention
|
2.2 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 1.0
|
|
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Follow-up
|
2.3 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.2
|
2.3 units on a scale
Standard Deviation 1.4
|
|
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Post-intervention
|
2.4 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Follow-up
|
2.3 units on a scale
Standard Deviation 1.3
|
2.2 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Physical Activity Subscale
Baseline
|
2.3 units on a scale
Standard Deviation 1.3
|
2.3 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Physical Activity Subscale
Post-intervention
|
2.4 units on a scale
Standard Deviation 1.3
|
2.7 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Physical Activity Subscale
Follow-up
|
2.2 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Measure of Self-Management Behaviors - Healthy Eating Subscale
Baseline
|
2.5 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Measure of Self-Management Behaviors - Healthy Eating Subscale
Post-intervention
|
2.7 units on a scale
Standard Deviation 1.1
|
3.0 units on a scale
Standard Deviation 1.1
|
|
Measure of Self-Management Behaviors - Healthy Eating Subscale
Follow-up
|
2.8 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Morisky Medication Adherence Scale
Baseline
|
1.5 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Morisky Medication Adherence Scale
Post-intervention
|
1.5 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Multidimensional Health Locus of Control (HLOC)
Baseline
|
26.1 units on a scale
Standard Deviation 5.9
|
26.4 units on a scale
Standard Deviation 5.9
|
|
Multidimensional Health Locus of Control (HLOC)
Post-intervention
|
25.5 units on a scale
Standard Deviation 6.3
|
27.0 units on a scale
Standard Deviation 4.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Maryland Assessment of Recovery Scale (MARS)
Baseline
|
3.8 units on a scale
Standard Deviation 0.7
|
3.9 units on a scale
Standard Deviation 0.7
|
|
Maryland Assessment of Recovery Scale (MARS)
Post-intervention
|
3.8 units on a scale
Standard Deviation 0.7
|
4.0 units on a scale
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Morisky Medication Adherence Scale
Baseline
|
1.5 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Morisky Medication Adherence Scale
Post-intervention
|
1.5 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
|
Morisky Medication Adherence Scale
Follow-up
|
1.4 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Multidimensional Health Locus of Control (HLOC)
Baseline
|
26.1 units on a scale
Standard Deviation 5.9
|
26.4 units on a scale
Standard Deviation 5.9
|
|
Multidimensional Health Locus of Control (HLOC)
Post-intervention
|
25.5 units on a scale
Standard Deviation 6.3
|
27.0 units on a scale
Standard Deviation 4.8
|
|
Multidimensional Health Locus of Control (HLOC)
Follow-up
|
25.7 units on a scale
Standard Deviation 5.5
|
26.6 units on a scale
Standard Deviation 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Medical Illness Education and Support Group
n=118 Participants
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.
|
Living Well
n=124 Participants
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.
|
|---|---|---|
|
Maryland Assessment of Recovery Scale (MARS)
Baseline
|
3.8 units on a scale
Standard Deviation 0.7
|
3.9 units on a scale
Standard Deviation 0.7
|
|
Maryland Assessment of Recovery Scale (MARS)
Post-intervention
|
3.8 units on a scale
Standard Deviation 0.7
|
4.0 units on a scale
Standard Deviation 0.7
|
|
Maryland Assessment of Recovery Scale (MARS)
Follow-up
|
3.8 units on a scale
Standard Deviation 0.7
|
4.0 units on a scale
Standard Deviation 0.7
|
Adverse Events
Living Well
Medical Illness Education and Support Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Living Well
n=124 participants at risk
Living Well (LW) will be implemented as a 12-session, peer-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 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.
|
Medical Illness Education and Support Group
n=118 participants at risk
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.
|
|---|---|---|
|
General disorders
Hospitalization
|
31.5%
39/124 • Number of events 53 • Adverse events assessed from time of enrollment to follow-up assessment (~9 months) for each participant. Total duration of reported events during recruitment and follow-up of study assessments is about 2 years, 8 months.
The reported All-Cause Mortality Affected and At Risk is zero as this study was deemed minimal risk and mortality due to study participation was not anticipated. In addition, there were no unanticipated deaths due to study participation.
|
25.4%
30/118 • Number of events 39 • Adverse events assessed from time of enrollment to follow-up assessment (~9 months) for each participant. Total duration of reported events during recruitment and follow-up of study assessments is about 2 years, 8 months.
The reported All-Cause Mortality Affected and At Risk is zero as this study was deemed minimal risk and mortality due to study participation was not anticipated. In addition, there were no unanticipated deaths due to study participation.
|
Additional Information
Mary Brighid Walsh
Department of Veterans Affairs, VAMHCS MIRECC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place