NCT02188732

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

6.6 years

First QC Date

July 9, 2014

Last Update Submit

August 25, 2021

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderDepression

Keywords

Community Mental HealthSerious Mental IllnessMedical ComorbiditySelf-ManagementAutomated TelehealthEarly Mortality

Outcome Measures

Primary Outcomes (3)

  • Change in Health Self-management

    Self Rated Abilities for Health Practices Scale

    Change from baseline at 4,8,12, and 24 months

  • Change in risk of early mortality

    Avoidable Mortality Risk Index

    Change from baseline at 4,8,12, and 24 months

  • Change in acute service use

    emergency room visits and hospitalizations

    Change from baseline at 4,8,12, and 24 months

Secondary Outcomes (3)

  • Change in mental health self-management

    Change from baseline at 4,8,12, and 24 months

  • Change in psychiatric symptom severity

    Change from baseline at 4,8,12, and 24 months

  • Change in acute care costs

    Change from baseline at 12 and 24 months

Other Outcomes (2)

  • Change in Subjective Health Status

    Change from baseline at 4,8,12, and 24 months

  • Change in Cardiovascular Risk Factors

    Change from baseline at 4,8,12, and 24 months

Study Arms (3)

CBHH+AT

EXPERIMENTAL

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+ATBehavioral: CBHH

CBHH+SMT

ACTIVE COMPARATOR

CBHH+SMT Community-Based Health Home (CBHH) PLUS Self-Management Training (SMT) of I-IMR I-IMR integrates psychiatric illness self-management with strategies for medical illness self-management . The psychiatric component includes psychoeducation about illness and treatment, cognitive behavioral approaches to increase medication adherence, training and relapse prevention, teaching coping skills to manage persistent symptoms, and social skills training. The medical illness component consists of an individually tailored curriculum focused on managing physical illnesses using parallel skills and strategies taught for psychiatric illness self-management, as well as a nurse health care manager to facilitate coordination of necessary preventive and ongoing health care. The I-IMR curriculum consists of 10 modules delivered by an I-IMR specialist through eight months of weekly sessions customized to the specific needs and disorders of each client.

Behavioral: CBHH+SMTBehavioral: CBHH

CBHH

ACTIVE COMPARATOR

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)

Behavioral: CBHH

Interventions

CBHH+ATBEHAVIORAL

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.

Also known as: Person and Family-Centered Health Home, Automated Telehealth, Health Buddy
CBHH+AT
CBHH+SMTBEHAVIORAL

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.).

Also known as: Illness Self-management, Self-mangement support, Integrated Illness Self-management and Recovery
CBHH+SMT
CBHHBEHAVIORAL

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).

Also known as: Patient centered health home, Behavioral health home, Chronic disease management
CBHHCBHH+ATCBHH+SMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bay Cove Human Services

Boston, Massachusetts, 02114, United States

Location

Vinfen

Cambridge, Massachusetts, 02141-1001, United States

Location

Related Publications (2)

  • Bartels SJ, Pratt SI, Mueser KT, Naslund JA, Wolfe RS, Santos M, Xie H, Riera EG. Integrated IMR for psychiatric and general medical illness for adults aged 50 or older with serious mental illness. Psychiatr Serv. 2014 Mar 1;65(3):330-7. doi: 10.1176/appi.ps.201300023.

    PMID: 24292559BACKGROUND

  • Pratt SI, Bartels SJ, Mueser KT, Naslund JA, Wolfe R, Pixley HS, Josephson L. Feasibility and effectiveness of an automated telehealth intervention to improve illness self-management in people with serious psychiatric and medical disorders. Psychiatr Rehabil J. 2013 Dec;36(4):297-305. doi: 10.1037/prj0000022.

    PMID: 24320837BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepression

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, of Community and Family Medicine, and of TDI

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 14, 2014

Study Start

January 1, 2015

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

US(2)