A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 4
- 主要终点
- Short Form-12 (SF-12) General Health (Norm Based)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- •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"
研究组 & 干预措施
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.
干预措施: Living Well (Behavioral)
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.
干预措施: Medical Illness Education & Support Group (Behavioral)
结局指标
主要结局
Short Form-12 (SF-12) General Health (Norm Based)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Measure of Self-Management Behaviors - Physical Activity Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Illness Management Self-Efficacy(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(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Patient Activation Measure(Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline))
- Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale(Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline))
- Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale(Baseline, Post-Intervention, Follow-up (6 months after baseline))
- Measure of Self-Management Behaviors - Accessing Social Support Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Measure of Self-Management Behaviors - Healthy Eating Subscale(Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline))
- Short-Form 12 (SF-12) Mental Scale (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))
- Short Form-12 (SF-12) General Health (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))
- Short-Form 12 (SF-12) Physical Scale (Norm Based)(Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline))