Wellness Self-Management

This study is currently recruiting participants.
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01676909
First received: July 2, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Veterans with schizophrenia and other serious mental illnesses (SMI) 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 our own evaluation of an intervention called Living Well), we propose to complete a randomized controlled effectiveness trial of our 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.


Condition Intervention
Mental Illness
Chronic Medical Illness
Behavioral: Living Well
Behavioral: Health Focused support and education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • SF-12 [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Illness Management Self-Efficacy [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    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.

  • Patient Activation Measure [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    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. The measure has demonstrated reliability and validity.

  • Measure of Self-Management Behaviors [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    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.

  • Morisky Medication Adherence Scale [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This 8 item self-reported medication adherence scale was developed from a well validated 4-item scale and supplemented with additional items to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties

  • Colorado Symptom Index [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    The CSI is a 14-item self report measure in which respondents report the frequency with which they experience specific symptoms over the past week, using a 4 point Likert scale that ranges from "not at all" to "at least every day". It is designed to provide a brief self-report index of psychiatric illness severity. The CSI has demonstrated excellent internal consistency, test-retest reliability, and validity indicators

  • Service Utilization Data [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    summaries of somatic and mental health service utilization

  • The Mental Illness Research, Education and Clinical Center (MIRECC) Demographic Form [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    The MIRECC Demographic form will be used to gather basic demographic information from the participant, including age, race, gender, living arrangement, etc.

  • Maryland Assessment of Recovery Scale [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale (strongly disagree to strongly agree). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)

  • The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): [ Time Frame: enrollment ] [ Designated as safety issue: No ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological screening battery that assesses memory, language, visuo-spatial/constructional ability, and attention. The RBANS has been shown to perform well as a clinical screening test and as an outcome measure for clinical trials in schizophrenia. As cognitive functioning may relate to study outcomes, RBANS scores will be used in exploratory analyses focusing on the relationship between various cognitive skills and related study outcomes. We will be using an abbreviated version.

  • Insomnia Severity Index (ISI) [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This measurement is a brief assessment (7 items) inquiring about the severity of a person's insomnia and sleep problems and patterns. It also questions their satisfaction level with their sleep, how worried or distressed they are, and how much they feel it is interfering in their daily functioning. All responses are on a 4 point Likert scale.

  • Medical Conditions (MCON) [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    A series of interview items drawn from the National Health and Nutrition Examination Survey III solicits the presence of lifetime and current co-occurring medical conditions and whether the patient is currently receiving treatment.

  • PAIN Measure [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This measure was created for this study. It consists of 4 Likert response questions from the Pain Numeric Rating Scale which is available on the Department of Veterans Affairs website under Clinical Tools for Pain Management that inquires about a person's level of pain. It also consists of a one yes/no question and one multiple choice response questions where both inquire about treatment of pain.

  • Participation with Services [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This questionnaire was created for this study. It is comprised of yes/no and Likert-response item questions concerning participants' exposure to and involvement in peer facilitated groups or individual encounters with peer-counselors that focus on both mental health as well as physical and medical health and wellness.

  • Substance Use and Health Behaviors (SUHB) [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This instrument inquires about the use of substances and the effects on healthy behaviors, specifically illicit drugs, alcohol, tobacco, and caffeine. It also queries about the treatment for substance use or abuse, and regular physical activity and exercise.

  • Multidimensional Health Locus of Control (HLOC): [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    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.

  • General Medical and Psychiatric Services (GMED) [ Time Frame: enrollment, randomization, post-treatment, 3 mo follow-up ] [ Designated as safety issue: No ]
    This assessment measures how frequently participants utilize general heal services, including primary medical doctors, specialists, emergency services, mental health services, and inpatient hospitalizations.


Estimated Enrollment: 250
Study Start Date: October 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Living Well
Living Well will be implemented as a 12 session small-group intervention (4-8 persons). 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.
Behavioral: Living Well
Living Well will be implemented as a 12 session small-group intervention (4-8 persons). 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.
Active Comparator: Medical Illness Education and Support Group
The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition. 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.
Behavioral: Health Focused support and education
The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition. 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.

Detailed Description:

Background:

Veterans with schizophrenia and other serious mental illnesses (SMI) 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 our own evaluation of an intervention called Living Well), we propose to complete a randomized controlled effectiveness trial of our 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 our Living Well intervention with 234 veterans with SMI and at least one co-occurring chronic medical condition and evaluate the intervention's effects on functional and service related outcomes. We 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. We 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. Our 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a diagnosis of schizophrenia/ schizoaffective disorder
  • bipolar disorder
  • major depression with psychotic features
  • or psychosis 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"
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676909

Contacts
Contact: Richard W Goldberg, PhD (410) 637-1863 Richard.Goldberg@va.gov

Locations
United States, District of Columbia
VA Central Office - HSR&D, Washington, DC Not yet recruiting
Washington, District of Columbia, United States, 20420
Contact: Julia Evelly410-637, MA    410-637-1866    julia.evelly@va.gov   
United States, Maryland
VA Maryland Health Care System, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Julia Evelly, MA    202-745-8000    julia.evelly@va.gov   
Principal Investigator: Richard W. Goldberg, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Richard W. Goldberg, PhD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01676909     History of Changes
Other Study ID Numbers: IIR 11-276
Study First Received: July 2, 2012
Last Updated: February 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
self-management

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014