Wellness Self-Management

Not Applicable

Completed

• Conditions: Chronic Medical Illness; Mental Illness
• Interventions: Behavioral: Living Well; Behavioral: Medical Illness Education & Support Group

• Registration Number: NCT01676909
• Lead Sponsor: VA Office of Research and Development

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-31
• Study Start: 2013-10-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Results First Submitted: 2018-01-02
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Results First Posted: 2019-06-06
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

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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"

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Short Form-12 (SF-12) General Health (Norm Based)	Baseline, Post-intervention (3 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
ER Visit Between Baseline and the 6-month Follow-up	Baseline, Follow-up (6-months after baseline)	Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
Short-Form 12 (SF-12) Physical Scale (Norm Based)	Baseline, Post-intervention (3 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Mental Scale (Norm Based)	Baseline, Post-intervention (3 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

Secondary Outcome Measures

Name	Time	Method
Measure of Self-Management Behaviors - Physical Activity Subscale	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
Illness Management Self-Efficacy	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)	This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
Patient Activation Measure	Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)	This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale	Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores 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 - Behavioral and Cognitive Symptom Management Subscale	Baseline, Post-Intervention, Follow-up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). 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	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores 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 - Healthy Eating Subscale	Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)	This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
Short-Form 12 (SF-12) Mental Scale (Norm Based)	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short Form-12 (SF-12) General Health (Norm Based)	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
Short-Form 12 (SF-12) Physical Scale (Norm Based)	Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)	12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.

Trial Locations

Locations (2)

Washington DC VA Medical Center, Washington, DC; 🇺🇸 Washington, District of Columbia, United States

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States