Evaluation of A Statewide Program to Prevent Early Mortality and to Promote Fitness in Persons With SMI

Completed · Not applicable

Conditions studied: Schizophrenia, Bipolar Disorder, Schizoaffective Disorder

In brief

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: 1. 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. 2. Evaluate system-level outcomes including: (a) consumer health behaviors and health indicators, (b) provider prescribing and program fidelity, and (c) acute services use.

Key facts

Study ID

NCT02334280

Run by

Dartmouth-Hitchcock Medical Center

People needed

120

Starts

2009-09-01

Expected to finish

2013-05-01

Last updated by the study team

2015-01-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Central Behavioral Health — Lebanon, New Hampshire, United States
• Mental Health Center of Greater Manchester — Manchester, New Hampshire, United States
• Greater Nashua Mental Health Center at Community Council — Nashua, New Hampshire, United States
• Center for Life Management — Salem, New Hampshire, United States

Full record on ClinicalTrials.gov

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