Clinical trial NCT01676909: Wellness Self-Management
Official title: A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Chronic Medical Illness
Keywords: self-management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-08-31
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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"

Primary outcomes:
measure: Short Form-12 (SF-12) General Health (Norm Based)
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Short-Form 12 (SF-12) Physical Scale (Norm Based)
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Short-Form 12 (SF-12) Mental Scale (Norm Based)
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: ER Visit Between Baseline and the 6-month Follow-up
timeFrame: Baseline, Follow-up (6-months after baseline)
Secondary outcomes:
measure: Illness Management Self-Efficacy
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Patient Activation Measure
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - Accessing Social Support Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - Physical Activity Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Measure of Self-Management Behaviors - Healthy Eating Subscale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Short Form-12 (SF-12) General Health (Norm Based)
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
measure: Short-Form 12 (SF-12) Physical Scale (Norm Based)
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
measure: Short-Form 12 (SF-12) Mental Scale (Norm Based)
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
measure: Illness Management Self-Efficacy
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
measure: Patient Activation Measure
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
measure: Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
measure: Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
measure: Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
timeFrame: Baseline, Post-Intervention, Follow-up (6 months after baseline)
measure: Measure of Self-Management Behaviors - Accessing Social Support Subscale
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
measure: Measure of Self-Management Behaviors - Physical Activity Subscale
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
measure: Measure of Self-Management Behaviors - Healthy Eating Subscale
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Other outcomes:
measure: Morisky Medication Adherence Scale
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Multidimensional Health Locus of Control (HLOC)
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Maryland Assessment of Recovery Scale (MARS)
timeFrame: Baseline, Post-intervention (3 months after baseline)
measure: Morisky Medication Adherence Scale
timeFrame: Baseline, Follow-up (6 months after baseline)
measure: Multidimensional Health Locus of Control (HLOC)
timeFrame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
measure: Maryland Assessment of Recovery Scale (MARS)
timeFrame: Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Richard W Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.