Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
Completed · Not applicable
Conditions studied: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression
In brief
This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses: Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management and greater mental health self-management. Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms. Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use and less acute service use costs.
Key facts
- Study ID
- NCT02188732
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 301
- Starts
- 2015-01-01
- Expected to finish
- 2021-07-31
- Last updated by the study team
- 2021-08-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 or older and enrolled in treatment for at least 3 months;
- SMI as defined by (i) primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; (ii) moderate impairment across multiple areas of psychosocial functioning, including social relationships, self-care, community/work activity, treatment self-management, and community living skills; (iii) GAF (Global Assessment of Functioning) score less than 61. The broad range of SMI are included primarily because findings will be more generalizable to routine mental health settings, but also because we included this group in our pilot studies;
- Diagnosis of one of the following medical illnesses or health conditions: diabetes, heart disease, chronic obstructive pulmonary disease, chronic pain, hyperlipidemia, hypertension, obesity, tobacco dependence;
- Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian;
- An expressed willingness to participate in self-management training or a telehealth program;
- Ability to read the telehealth display in English.
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 12-24 months; or
- Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE)74 score <24.
Where it is running
- Bay Cove Human Services — Boston, Massachusetts, United States
- Vinfen — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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