<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02188732</url>
  </required_header>
  <id_info>
    <org_study_id>11522753</org_study_id>
    <nct_id>NCT02188732</nct_id>
  </id_info>
  <brief_title>Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes</brief_title>
  <official_title>Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and&#xD;
      medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone&#xD;
      (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also&#xD;
      receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3&#xD;
      hypotheses:&#xD;
&#xD;
      Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater&#xD;
      health self-management and greater mental health self-management.&#xD;
&#xD;
      Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater&#xD;
      reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.&#xD;
&#xD;
      Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute&#xD;
      service use and less acute service use costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Efforts to reduce early mortality in persons with serious mental illness (SMI) have largely&#xD;
      focused on providing integrated primary care in a &quot;health home&quot;. Yet medical care alone&#xD;
      accounts for a disproportionately small contribution to reductions in early morality in&#xD;
      comparison to improving self-management and health behaviors. Illness self-management&#xD;
      training (SMT) in the general population has been shown to improve health outcomes and lower&#xD;
      costs associated with chronic health conditions by teaching and coaching individuals on&#xD;
      monitoring symptoms, self-administering treatments, and improving health behaviors. More&#xD;
      recently, the use of technologies such as Automated Telehealth (AT) has been shown to improve&#xD;
      outcomes and potentially prevent expensive emergency room and acute hospitalizations in the&#xD;
      general population by daily prompting of self-management and remote monitoring by a nurse who&#xD;
      can pre-emptively intervene, guided by disease management algorithms. To the investigators&#xD;
      knowledge, neither of these approaches has been empirically evaluated as an integrated&#xD;
      component in a behavioral health home for persons with SMI. The investigators will conduct a&#xD;
      randomized clinical trial (RCT) of 300 persons with SMI and medical comorbidity to evaluate&#xD;
      outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also&#xD;
      receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth&#xD;
      (CBHH+AT). The investigators will test the following 3 hypotheses:&#xD;
&#xD;
      Primary H1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater&#xD;
      health self-management (measured by the Self Rated Abilities for Health Practices Scale) and&#xD;
      (Exploratory E1) greater mental health self-management (measured by the Illness Management&#xD;
      and Recovery Scale) at 4, 8, 12, and 24-months. Primary H2: CBHH+SMT and CBHH+AT compared to&#xD;
      CBHH alone, will be associated with greater reduction in risk of early mortality (as measured&#xD;
      by the Avoidable Mortality Risk Index) and (Exploratory E2) in psychiatric symptoms (BPRS) at&#xD;
      4, 8, 12, and 24 months. Primary H3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be&#xD;
      associated with less acute service use (emergency room visits and hospitalizations) and&#xD;
      (Exploratory E3) less acute service use costs at 4, 8, 12, and 24-months.&#xD;
&#xD;
      In order to differentiate CBHH+SMT and CBHH+AT if both are found to be effective, the&#xD;
      investigators will evaluate the persistence of primary outcomes from intervention endpoint&#xD;
      (at 12 months) to the final follow-up (at 24 months) and will calculate the additional&#xD;
      incremental costs of implementing and providing SMT and AT. The investigators will also&#xD;
      explore differences in subjective health (SF-12) and in individual cardiovascular risk&#xD;
      factors (e.g., BMI, tobacco use, blood pressure, glucose, lipids), comparing CBHH+SMT,&#xD;
      CBHH+AT, and CBHH alone. Finally, the investigators will explore hypothesized mechanisms of&#xD;
      action (potential mediators) for the Aim 2 primary outcome of reduced risk of early mortality&#xD;
      (i.e., improvement in health self-management) and for the Aim 3 primary outcome of less acute&#xD;
      service use (i.e., medication adherence and number of nurse preemptive interventions).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Health Self-management</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>Self Rated Abilities for Health Practices Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in risk of early mortality</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>Avoidable Mortality Risk Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in acute service use</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>emergency room visits and hospitalizations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mental health self-management</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>Illness Management and Recovery Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychiatric symptom severity</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>Brief Psychiatric Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in acute care costs</measure>
    <time_frame>Change from baseline at 12 and 24 months</time_frame>
    <description>emergency room and hospitalization costs</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Subjective Health Status</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>SF-12</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Cardiovascular Risk Factors</measure>
    <time_frame>Change from baseline at 4,8,12, and 24 months</time_frame>
    <description>BMI, Tobacco Use, Blood Pressure, Glucose, Lipids</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">301</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>CBHH+AT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community Based Health Home + Automated Telehealth (CBHH+AT):&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBHH+SMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CBHH+SMT Community-Based Health Home (CBHH) PLUS Self-Management Training (SMT) of I-IMR&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBHH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBHH+AT</intervention_name>
    <description>Community Based Health Home + Automated Telehealth (CBHH+AT):&#xD;
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.</description>
    <arm_group_label>CBHH+AT</arm_group_label>
    <other_name>Person and Family-Centered Health Home</other_name>
    <other_name>Automated Telehealth</other_name>
    <other_name>Health Buddy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBHH+SMT</intervention_name>
    <description>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.).</description>
    <arm_group_label>CBHH+SMT</arm_group_label>
    <other_name>Illness Self-management</other_name>
    <other_name>Self-mangement support</other_name>
    <other_name>Integrated Illness Self-management and Recovery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBHH</intervention_name>
    <description>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).</description>
    <arm_group_label>CBHH</arm_group_label>
    <arm_group_label>CBHH+AT</arm_group_label>
    <arm_group_label>CBHH+SMT</arm_group_label>
    <other_name>Patient centered health home</other_name>
    <other_name>Behavioral health home</other_name>
    <other_name>Chronic disease management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older and enrolled in treatment for at least 3 months;&#xD;
&#xD;
          2. SMI as defined by (i) primary DSM-IV (Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, Fourth Edition) Axis I diagnosis of schizophrenia, schizoaffective&#xD;
             disorder, bipolar disorder, or major depressive disorder; (ii) moderate impairment&#xD;
             across multiple areas of psychosocial functioning, including social relationships,&#xD;
             self-care, community/work activity, treatment self-management, and community living&#xD;
             skills; (iii) GAF (Global Assessment of Functioning) score less than 61. The broad&#xD;
             range of SMI are included primarily because findings will be more generalizable to&#xD;
             routine mental health settings, but also because we included this group in our pilot&#xD;
             studies;&#xD;
&#xD;
          3. Diagnosis of one of the following medical illnesses or health conditions: diabetes,&#xD;
             heart disease, chronic obstructive pulmonary disease, chronic pain, hyperlipidemia,&#xD;
             hypertension, obesity, tobacco dependence;&#xD;
&#xD;
          4. Voluntary informed consent for participation in the study by the participant or by the&#xD;
             participant's legally designated guardian;&#xD;
&#xD;
          5. An expressed willingness to participate in self-management training or a telehealth&#xD;
             program;&#xD;
&#xD;
          6. Ability to read the telehealth display in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently residing in a nursing home or group home;&#xD;
&#xD;
          2. Terminal physical illness expected to result in the death of the study subject within&#xD;
             12-24 months; or&#xD;
&#xD;
          3. Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant&#xD;
             cognitive impairment as indicated by a Mini Mental State Examination (MMSE)74 score&#xD;
             &lt;24.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bay Cove Human Services</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinfen</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02141-1001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24292559</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24320837</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Stephen J. Bartels</investigator_full_name>
    <investigator_title>Professor of Psychiatry, of Community and Family Medicine, and of TDI</investigator_title>
  </responsible_party>
  <keyword>Community Mental Health</keyword>
  <keyword>Serious Mental Illness</keyword>
  <keyword>Medical Comorbidity</keyword>
  <keyword>Self-Management</keyword>
  <keyword>Automated Telehealth</keyword>
  <keyword>Early Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02188732
org study id: 11522753
nct id: NCT02188732
lead sponsor: 
collaborator: 
has dmc: Yes
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in Health Self-management
time frame: Change from baseline at 4,8,12, and 24 months
description: Self Rated Abilities for Health Practices Scale
measure: Change in risk of early mortality
time frame: Change from baseline at 4,8,12, and 24 months
description: Avoidable Mortality Risk Index
measure: Change in acute service use
time frame: Change from baseline at 4,8,12, and 24 months
description: emergency room visits and hospitalizations
measure: Change in mental health self-management
time frame: Change from baseline at 4,8,12, and 24 months
description: Illness Management and Recovery Scale
measure: Change in psychiatric symptom severity
time frame: Change from baseline at 4,8,12, and 24 months
description: Brief Psychiatric Rating Scale
measure: Change in acute care costs
time frame: Change from baseline at 12 and 24 months
description: emergency room and hospitalization costs
measure: Change in Subjective Health Status
time frame: Change from baseline at 4,8,12, and 24 months
description: SF-12
measure: Change in Cardiovascular Risk Factors
time frame: Change from baseline at 4,8,12, and 24 months
description: BMI, Tobacco Use, Blood Pressure, Glucose, Lipids
arm group label: CBHH+AT
arm group type: Experimental
description: 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.
arm group label: CBHH+SMT
arm group type: Active Comparator
description: 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.
arm group label: CBHH
arm group type: Active Comparator
description: 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)
intervention type: Behavioral
intervention name: CBHH+AT
description: 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.
arm group label: CBHH+AT
other name: Person and Family-Centered Health Home
other name: Automated Telehealth
other name: Health Buddy
intervention type: Behavioral
intervention name: CBHH+SMT
description: 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.).
arm group label: CBHH+SMT
other name: Illness Self-management
other name: Self-mangement support
other name: Integrated Illness Self-management and Recovery
intervention type: Behavioral
intervention name: CBHH
description: 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).
arm group label: CBHH
arm group label: CBHH+AT
arm group label: CBHH+SMT
other name: Patient centered health home
other name: Behavioral health home
other name: Chronic disease management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
citation: 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: 24292559
citation: 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: 24320837
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Stephen J. Bartels
investigator title: Professor of Psychiatry, of Community and Family Medicine, and of TDI
mesh term: Schizophrenia
mesh term: Bipolar Disorder
mesh term: Psychotic Disorders