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

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ClinicalTrials.gov Identifier: NCT02188732
Recruitment Status : Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephen J. Bartels, Dartmouth-Hitchcock Medical Center

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Depression Behavioral: CBHH+AT Behavioral: CBHH+SMT Behavioral: CBHH Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
Actual Study Start Date : January 2015
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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+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.

Other Names:
  • Person and Family-Centered Health Home
  • Automated Telehealth
  • Health Buddy

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).
Other Names:
  • Patient centered health home
  • Behavioral health home
  • Chronic disease management

Active Comparator: CBHH+SMT

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+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.).
Other Names:
  • Illness Self-management
  • Self-mangement support
  • Integrated Illness Self-management and Recovery

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).
Other Names:
  • Patient centered health home
  • Behavioral health home
  • Chronic disease management

Active Comparator: 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)
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).
Other Names:
  • Patient centered health home
  • Behavioral health home
  • Chronic disease management




Primary Outcome Measures :
  1. Change in Health Self-management [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    Self Rated Abilities for Health Practices Scale

  2. Change in risk of early mortality [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    Avoidable Mortality Risk Index

  3. Change in acute service use [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    emergency room visits and hospitalizations


Secondary Outcome Measures :
  1. Change in mental health self-management [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    Illness Management and Recovery Scale

  2. Change in psychiatric symptom severity [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    Brief Psychiatric Rating Scale

  3. Change in acute care costs [ Time Frame: Change from baseline at 12 and 24 months ]
    emergency room and hospitalization costs


Other Outcome Measures:
  1. Change in Subjective Health Status [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    SF-12

  2. Change in Cardiovascular Risk Factors [ Time Frame: Change from baseline at 4,8,12, and 24 months ]
    BMI, Tobacco Use, Blood Pressure, Glucose, Lipids



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188732


Locations
Layout table for location information
United States, Massachusetts
Bay Cove Human Services
Boston, Massachusetts, United States, 02114
Vinfen
Cambridge, Massachusetts, United States, 02141-1001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Publications:
Layout table for additonal information
Responsible Party: Stephen J. Bartels, Professor of Psychiatry, of Community and Family Medicine, and of TDI, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02188732    
Other Study ID Numbers: 11522753
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: April 2020
Keywords provided by Stephen J. Bartels, Dartmouth-Hitchcock Medical Center:
Community Mental Health
Serious Mental Illness
Medical Comorbidity
Self-Management
Automated Telehealth
Early Mortality
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders