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

Summary

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Bipolar Disorder
• Depression

Interventions

BEHAVIORAL

CBHH+AT

Community Based Health Home + Automated Telehealth (CBHH+AT): Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk.

BEHAVIORAL

CBHH+SMT

Illness Management and Recovery (IMR) for psychiatric illness combines (1) psychoeducation, which improves knowledge about mental illness management, (2) behavioral tailoring, which improves medication adherence, (3) relapse prevention training, which decreases relapses and rehospitalizations, and (4) coping skills training, which reduces distress related to symptoms. Illness Management and Recovery (I-IMR) by adding chronic medical illness self-management to psychiatric illness self-management. For each psychiatric self-management skill module, there is a corresponding medical illness self-management training component using established methods in self-management of common chronic health conditions (e.g., diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, etc.).

BEHAVIORAL

CBHH

Community-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Dartmouth-Hitchcock Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2021-07-31

Completion

2021-07-31

Countries

• United States

Study Locations