Mental IllnessNCT01676909
Wellness Self-Management
A study testing Living Well and Medical Illness Education & Support Group in people with Mental Illness and Chronic Medical Illness, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mental Illness, Chronic Medical Illness
- What is being tested?
- Living Well and Medical Illness Education & Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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"
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
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.
Read the 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.
- Conditions
- Mental Illness, Chronic Medical Illness
- Being tested
- Living Well, Medical Illness Education & Support Group
- Keywords
- self-management
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living WellBehavioural
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.
Medical Illness Education & Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Living Well | Experimental | 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. Receives: Behavioral: Living Well |
| Medical Illness Education & Support Group | Active comparator | 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. Receives: Behavioral: Medical Illness Education & Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Follow-up (6-months after baseline)
Secondary outcomes (19)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-intervention (3 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
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
Measured: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention, Follow-up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
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.
Measured: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study start1 Oct 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard W Goldberg, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676909
- Sponsor's protocol ID
- IIR 11-276
- Status last verified
- Feb 2019
- First submitted
- 2 Jul 2012
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33588639
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
- ClinicalTrials.gov ID
- NCT01676909
- Acronym / sponsor ID
- IIR 11-276
- Conditions
- Mental Illness, Chronic Medical Illness
- Keywords
- self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living Well | Experimental | Behavioral: Living WellThis 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 | Active comparator | Behavioral: Medical Illness Education & Support GroupWe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- a diagnosis of schizophrenia/ schizoaffective disorder
- bipolar disorder
- major depression with psychotic features
- post traumatic stress disorder
- or psychosis not otherwise specified (NOS)
Key exclusion criteria (3 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living WellThis 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. | Behavioural | Living Well |
| Medical Illness Education & Support GroupThe 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. | Behavioural | Medical Illness Education & Support Group |
Primary outcome
Short Form-12 (SF-12) General Health (Norm Based)
Time frame: 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.
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Time frame: 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)
Time frame: 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.
ER Visit Between Baseline and the 6-month Follow-up
Time frame: Baseline, Follow-up (6-months after baseline)
Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
19 secondary outcomes
Illness Management Self-Efficacy
Time frame: Baseline, Post-intervention (3 months after baseline)
Patient Activation Measure
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - Physical Activity Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Measure of Self-Management Behaviors - Healthy Eating Subscale
Time frame: Baseline, Post-intervention (3 months after baseline)
Short Form-12 (SF-12) General Health (Norm Based)
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Short-Form 12 (SF-12) Physical Scale (Norm Based)
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Short-Form 12 (SF-12) Mental Scale (Norm Based)
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Illness Management Self-Efficacy
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
Patient Activation Measure
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
Time frame: Baseline, Post-Intervention, Follow-up (6 months after baseline)
Measure of Self-Management Behaviors - Accessing Social Support Subscale
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Measure of Self-Management Behaviors - Physical Activity Subscale
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Measure of Self-Management Behaviors - Healthy Eating Subscale
Time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33588639Muralidharan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Goldberg, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Well and Medical Illness Education & Support Group in people with Mental Illness and Chronic Medical Illness, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form-12 (SF-12) General Health (Norm Based) (time frame: Baseline, Post-intervention (3 months after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01676909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.