Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes



Status:Active, not recruiting
Conditions:Depression, Depression, Schizophrenia, Psychiatric, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:7/26/2018
Start Date:January 2015
End Date:August 2019

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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.

Efforts to reduce early mortality in persons with serious mental illness (SMI) have largely
focused on providing integrated primary care in a "health home". Yet medical care alone
accounts for a disproportionately small contribution to reductions in early morality in
comparison to improving self-management and health behaviors. Illness self-management
training (SMT) in the general population has been shown to improve health outcomes and lower
costs associated with chronic health conditions by teaching and coaching individuals on
monitoring symptoms, self-administering treatments, and improving health behaviors. More
recently, the use of technologies such as Automated Telehealth (AT) has been shown to improve
outcomes and potentially prevent expensive emergency room and acute hospitalizations in the
general population by daily prompting of self-management and remote monitoring by a nurse who
can pre-emptively intervene, guided by disease management algorithms. To the investigators
knowledge, neither of these approaches has been empirically evaluated as an integrated
component in a behavioral health home for persons with SMI. The investigators will conduct a
randomized clinical trial (RCT) of 300 persons with SMI and medical comorbidity to 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:

Primary H1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater
health self-management (measured by the Self Rated Abilities for Health Practices Scale) and
(Exploratory E1) greater mental health self-management (measured by the Illness Management
and Recovery Scale) at 4, 8, 12, and 24-months. Primary H2: CBHH+SMT and CBHH+AT compared to
CBHH alone, will be associated with greater reduction in risk of early mortality (as measured
by the Avoidable Mortality Risk Index) and (Exploratory E2) in psychiatric symptoms (BPRS) at
4, 8, 12, and 24 months. Primary H3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be
associated with less acute service use (emergency room visits and hospitalizations) and
(Exploratory E3) less acute service use costs at 4, 8, 12, and 24-months.

In order to differentiate CBHH+SMT and CBHH+AT if both are found to be effective, the
investigators will evaluate the persistence of primary outcomes from intervention endpoint
(at 12 months) to the final follow-up (at 24 months) and will calculate the additional
incremental costs of implementing and providing SMT and AT. The investigators will also
explore differences in subjective health (SF-12) and in individual cardiovascular risk
factors (e.g., BMI, tobacco use, blood pressure, glucose, lipids), comparing CBHH+SMT,
CBHH+AT, and CBHH alone. Finally, the investigators will explore hypothesized mechanisms of
action (potential mediators) for the Aim 2 primary outcome of reduced risk of early mortality
(i.e., improvement in health self-management) and for the Aim 3 primary outcome of less acute
service use (i.e., medication adherence and number of nurse preemptive interventions).

Inclusion Criteria:

1. Age 18 or older and enrolled in treatment for at least 3 months;

2. 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;

3. 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;

4. Voluntary informed consent for participation in the study by the participant or by the
participant's legally designated guardian;

5. An expressed willingness to participate in self-management training or a telehealth
program;

6. Ability to read the telehealth display in English.

Exclusion Criteria:

1. Currently residing in a nursing home or group home;

2. Terminal physical illness expected to result in the death of the study subject within
12-24 months; or

3. 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.
We found this trial at
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Boston, Massachusetts 02114
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Cambridge, Massachusetts 02141
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Cambridge, MA
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