Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Change in exercise capacity
研究概览
简要总结
The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:
- Evaluate person-level and provider-level outcomes including: (a) consumer health behaviors, health indicators, mental health indicators, and acute health service utilization, (b) provider prescribing practices and program fidelity, and (c) program costs.
- Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.
详细描述
Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older
- •Serious mental illness defined by (a) an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia, (b) moderate impairment across multiple areas of psychological functioning, or (c) Global Assessment of Functioning (GAF) score less than 61
- •Able to provide voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator
- •Poor fitness as indicated by BMI > 25 or failure to adhere to the US Department of Health and Human Services Physical Activity Guidelines for Americans, i.e., at least 2.5 hr/week of moderate or 75 min/week of vigorous activity in more than one session
- •Medical clearance for participation in an exercise and dietary modification program by a physician, physician assistant, or nurse practitioner
- •An expressed willingness to participate in a diet and exercise program
- •Currently taking an atypical antipsychotic medication
- •Able to walk a city block
- •Responsible for choice of foods and how they are prepared
排除标准
- •Currently residing in a nursing home or group home
- •Terminal physical illness expected to result in the death of the study subject within one year
- •Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini-Mental State Examination (MMSE) score < 24
- •Inability to speak and understand English
- •Pregnancy
结局指标
主要结局
Change in exercise capacity
时间窗: baseline, 6-, 12-, and 24-months
Change in exercise capacity measured by the 6-minute walk test.
次要结局
- Change in eating behavior(baseline, 6-, 12-, and 24-months)
- Change in physical measurement(baseline, 6-, 12-, and 24-months)
- Change in psychological functioning (depression, negative symptoms, and self-efficacy).(baseline, 6-, 12-, and 24-months)
- Change in social functioning(baseline, 6-, 12-, and 24-months)
- Self-reported physical activity(baseline, 6-, 12-, and 24-months)
- Change in social support and exercise(baseline, 6-, 12-, and 24-months)
- Change in service use(baseline, 6-, 12-, and 24-months)
- Change in dietary behaviors(baseline, 6-, 12-, and 24-months)
- Change in stage of change(baseline, 6-, 12-, and 24-months)
- Change in smoking and substance use(baseline, 6-, 12-, and 24-months)
- Change in family contact(baseline, 6-, 12-, and 24-months)
- Change in medications(baseline, 6-, 12-, and 24-months)
- Change in social support and eating habits(baseline, 6-, 12-, and 24-months)
- Change in comorbid medical illness(baseline, 6-, 12-, and 24-months)