search
Back to results

Wellness Self-Management

Primary Purpose

Mental Illness, Chronic Medical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Living Well
Medical Illness Education & Support Group
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Illness focused on measuring self-management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a diagnosis of schizophrenia/ schizoaffective disorder
  • bipolar disorder
  • major depression with psychotic features
  • post traumatic stress disorder
  • or psychosis not otherwise specified (NOS)
  • age between 18 and 80
  • chart documented presence of at least one of the following chronic medical conditions:

    • a respiratory condition (e.g. asthma, COPD)
    • diabetes
    • arthritis
    • cardiovascular condition (e.g. congestive heart failure, hypertension, etc.)
  • receiving mental health services at a designated study site
  • willing and able to provide consent to participate
  • deemed clinically stable enough to participate in the study by a treatment provider

Exclusion Criteria:

  • Severe or profound mental retardation
  • Because participants must be able to attend the intervention if assigned to either condition, we will also require potential participants to verify their availability during screening
  • Participation in current ongoing study 'Reducing Internalized Stigma in People with Serious Mental Illness"

Sites / Locations

  • Washington DC VA Medical Center, Washington, DC
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Living Well

Medical Illness Education & Support Group

Arm Description

This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.

We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.

Outcomes

Primary Outcome Measures

Short Form-12 (SF-12) General Health (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Physical Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Mental Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
ER Visit Between Baseline and the 6-month Follow-up
Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.

Secondary Outcome Measures

Illness Management Self-Efficacy
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.
Patient Activation Measure
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.
Measure of Self-Management Behaviors - Accessing Social Support Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Physical Activity Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Healthy Eating Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Short Form-12 (SF-12) General Health (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Physical Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Mental Scale (Norm Based)
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Illness Management Self-Efficacy
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
Patient Activation Measure
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Accessing Social Support Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Measure of Self-Management Behaviors - Physical Activity Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
Measure of Self-Management Behaviors - Healthy Eating Subscale
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.

Full Information

First Posted
July 2, 2012
Last Updated
February 27, 2019
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01676909
Brief Title
Wellness Self-Management
Official Title
A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.
Detailed Description
Background: Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care. Aims: Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well intervention with 242 Veterans with mental illness and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. The investigators hypothesize that those randomized to the Living Well intervention will, in comparison to those randomized to a medical illness education and support group, demonstrate improved general health functioning including physical and emotional functioning as well as reduced rates of medical emergency room visits for management of a chronic medical condition. The investigators will also evaluate intervention effects on more proximal attitudinal and behavioral outcomes and assess how these factors mediate improvement in the functional and services related outcomes. Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation framework to better understand contextual factors that can improve the Reach, Effectiveness, Adoption, Implementation and Maintenance which together determine the potential public health impact of the Living Well intervention. Methods: A mix of temporally overlapping quantitative and qualitative methods will be used to maximize integration and synthesis of data streams across the two aims to optimize knowledge accrual. Impact: Despite the growing recognition that self-management strategies hold enormous promise for improving quality and outcomes of care for chronic medical illnesses, and the fact that self-management is gaining prominence as a mental health recovery oriented treatment focus, there are currently no evidence-based peer facilitated medical illness self-management interventions available for dissemination within the VA mental health system. The proposed study is designed to both generate evidence supporting the effectiveness of a peer co-facilitated intervention and to help speed throughput to public health impact by collecting important contextual information about factors that may improve future dissemination and implementation efforts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Chronic Medical Illness
Keywords
self-management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Living Well
Arm Type
Experimental
Arm Description
This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.
Arm Title
Medical Illness Education & Support Group
Arm Type
Active Comparator
Arm Description
We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.
Intervention Type
Behavioral
Intervention Name(s)
Living Well
Intervention Description
This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Medical Illness Education & Support Group
Intervention Description
The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.
Primary Outcome Measure Information:
Title
Short Form-12 (SF-12) General Health (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
ER Visit Between Baseline and the 6-month Follow-up
Description
Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Time Frame
Baseline, Follow-up (6-months after baseline)
Secondary Outcome Measure Information:
Title
Illness Management Self-Efficacy
Description
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Patient Activation Measure
Description
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - Physical Activity Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Measure of Self-Management Behaviors - Healthy Eating Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Short Form-12 (SF-12) General Health (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Title
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Title
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Description
12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Title
Illness Management Self-Efficacy
Description
This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Title
Patient Activation Measure
Description
This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Title
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Title
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Title
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-Intervention, Follow-up (6 months after baseline)
Title
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Title
Measure of Self-Management Behaviors - Physical Activity Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Title
Measure of Self-Management Behaviors - Healthy Eating Subscale
Description
This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Other Pre-specified Outcome Measures:
Title
Morisky Medication Adherence Scale
Description
This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Multidimensional Health Locus of Control (HLOC)
Description
Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Maryland Assessment of Recovery Scale (MARS)
Description
The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.
Time Frame
Baseline, Post-intervention (3 months after baseline)
Title
Morisky Medication Adherence Scale
Description
Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
Time Frame
Baseline, Follow-up (6 months after baseline)
Title
Multidimensional Health Locus of Control (HLOC)
Description
Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
Time Frame
Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Title
Maryland Assessment of Recovery Scale (MARS)
Description
The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)
Time Frame
Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of schizophrenia/ schizoaffective disorder bipolar disorder major depression with psychotic features post traumatic stress disorder or psychosis not otherwise specified (NOS) age between 18 and 80 chart documented presence of at least one of the following chronic medical conditions: a respiratory condition (e.g. asthma, COPD) diabetes arthritis cardiovascular condition (e.g. congestive heart failure, hypertension, etc.) receiving mental health services at a designated study site willing and able to provide consent to participate deemed clinically stable enough to participate in the study by a treatment provider Exclusion Criteria: Severe or profound mental retardation Because participants must be able to attend the intervention if assigned to either condition, we will also require potential participants to verify their availability during screening Participation in current ongoing study 'Reducing Internalized Stigma in People with Serious Mental Illness"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Goldberg, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33588639
Citation
Muralidharan A, Peeples A, Lucksted A. Health Behavior Change Processes Among Adults With Serious Mental Illness Engaged in Illness Self-Management. Qual Health Res. 2021 May;31(6):1155-1168. doi: 10.1177/1049732321992049. Epub 2021 Feb 15.
Results Reference
derived

Learn more about this trial

Wellness Self-Management

We'll reach out to this number within 24 hrs