Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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