<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/NCT03023332</url>
  </required_header>
  <id_info>
    <org_study_id>1R01NR016817-01</org_study_id>
    <nct_id>NCT03023332</nct_id>
  </id_info>
  <brief_title>Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers</brief_title>
  <official_title>Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      How do varying levels of participation in selecting self-management interventions (ranging&#xD;
      from no input into the selection to selection based on need or preference) affect health&#xD;
      risks and physical and mental health over time in family caregivers of persons with bipolar&#xD;
      disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2)&#xD;
      education (usual care); 3) self-management intervention based on need (SM-need); or 4)&#xD;
      self-management intervention of their preference (SM-preference).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has two aims: The primary aim (A1) is to examine differences across the four groups&#xD;
      (control, usual care, SM-need, and SM-preference) on caregiver health (health risks and&#xD;
      mental and physical health) over time. We hypothesize that the caregivers who receive a&#xD;
      self-management intervention based on need (SM-need) or preference (SM-preference) will have&#xD;
      better health outcomes than those in the usual care or control groups.&#xD;
&#xD;
      Secondary aims are to: A2) explore whether caregiver baseline need or preference for&#xD;
      intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver&#xD;
      reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/&#xD;
      contextual factors that are associated with their needs and preferences for the&#xD;
      self-management interventions.&#xD;
&#xD;
      All caregivers will complete assessment measures and measures of health risks, and physical&#xD;
      and mental health at baseline (T1), 6 months (T2) and 12 months (T3). Caregivers will&#xD;
      randomly assigned to one of four groups. The control group will receive no intervention. The&#xD;
      usual care group will receive bipolar education. The SM-need group will receive a&#xD;
      self-management intervention tailored to meet their need for bipolar education, biofeedback&#xD;
      training, or resourcefulness training, as determined by baseline cut scores. Caregivers in&#xD;
      the SM-preference group will choose one of the three self-management intervention according&#xD;
      to their personal preference.&#xD;
&#xD;
      All three self-management interventions (bipolar education, biofeedback training,&#xD;
      resourcefulness training) are delivered over four weeks (between T1 and T2). Caregivers may&#xD;
      use the one SM intervention whenever and as often as they wish (i.e. self-tailoring) for the&#xD;
      remainder of the study period. The bipolar education and resourcefulness training&#xD;
      interventions will be delivered initially using an iPad. These interventions involve&#xD;
      providing educational information about bipolar disorder or teaching self-help&#xD;
      (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback&#xD;
      training consists of use of a hand-held device that shows the participant their changes in&#xD;
      heart rate based on changes in their breathing pattern (as they relax); caregivers who need&#xD;
      or prefer the biofeedback will be given a device to use for 28 days. All study participants&#xD;
      receiving the intervention will also be asked to keep a journal to record their experience&#xD;
      with the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A1) Caregiver health</measure>
    <time_frame>12 months</time_frame>
    <description>Examine differences across the four groups (control, usual care, SM-need, SM-preference) on caregiver health (health risks and mental and physical health) over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A2) Caregiver baseline need / preference association</measure>
    <time_frame>12 months</time_frame>
    <description>Explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A3) Build caregiver profiles</measure>
    <time_frame>12 months</time_frame>
    <description>Build caregiver profiles from demographic / contextual factors that are associated with their needs and preferences for the self-management interventions.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Distress</condition>
  <condition>Caregiver</condition>
  <arm_group>
    <arm_group_label>Self-management need</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-management preference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention or treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bipolar education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resourcefulness Training</intervention_name>
    <description>A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.</description>
    <arm_group_label>Self-management need</arm_group_label>
    <arm_group_label>Self-management preference</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback training</intervention_name>
    <description>Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate &quot;feedback&quot; to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and continue to influence behavior.</description>
    <arm_group_label>Self-management need</arm_group_label>
    <arm_group_label>Self-management preference</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bipolar Education</intervention_name>
    <description>An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.</description>
    <arm_group_label>Self-management need</arm_group_label>
    <arm_group_label>Self-management preference</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Have a family member with bipolar disorder&#xD;
&#xD;
          -  Have cared/supported them for at least the last 6 months in the last year&#xD;
&#xD;
          -  Be capable of performing the informed consent and participate in interventions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not have family member with bipolar disorder&#xD;
&#xD;
          -  Has not cared for family member for at least 6 months in the last year&#xD;
&#xD;
          -  Knowledge of another family member in the same household enrolled in the study&#xD;
&#xD;
          -  Is pregnant&#xD;
&#xD;
          -  Has a pacemaker&#xD;
&#xD;
          -  Lives outside of the study area (Cuyahoga, Lake, Geauga, Portage, Summit, Medina, and&#xD;
             Lorain counties)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CWRU School of Nursing</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Jaclene A. Zauszniewski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Caregiver</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Resourcefulness</keyword>
  <keyword>Self-Management</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03023332
org study id: 1R01NR016817-01
nct id: NCT03023332
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
How do varying levels of participation in selecting self-management interventions (ranging
      from no input into the selection to selection based on need or preference) affect health
      risks and physical and mental health over time in family caregivers of persons with bipolar
      disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2)
      education (usual care); 3) self-management intervention based on need (SM-need); or 4)
      self-management intervention of their preference (SM-preference).
The study has two aims: The primary aim (A1) is to examine differences across the four groups
      (control, usual care, SM-need, and SM-preference) on caregiver health (health risks and
      mental and physical health) over time. We hypothesize that the caregivers who receive a
      self-management intervention based on need (SM-need) or preference (SM-preference) will have
      better health outcomes than those in the usual care or control groups.

      Secondary aims are to: A2) explore whether caregiver baseline need or preference for
      intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver
      reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/
      contextual factors that are associated with their needs and preferences for the
      self-management interventions.

      All caregivers will complete assessment measures and measures of health risks, and physical
      and mental health at baseline (T1), 6 months (T2) and 12 months (T3). Caregivers will
      randomly assigned to one of four groups. The control group will receive no intervention. The
      usual care group will receive bipolar education. The SM-need group will receive a
      self-management intervention tailored to meet their need for bipolar education, biofeedback
      training, or resourcefulness training, as determined by baseline cut scores. Caregivers in
      the SM-preference group will choose one of the three self-management intervention according
      to their personal preference.

      All three self-management interventions (bipolar education, biofeedback training,
      resourcefulness training) are delivered over four weeks (between T1 and T2). Caregivers may
      use the one SM intervention whenever and as often as they wish (i.e. self-tailoring) for the
      remainder of the study period. The bipolar education and resourcefulness training
      interventions will be delivered initially using an iPad. These interventions involve
      providing educational information about bipolar disorder or teaching self-help
      (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback
      training consists of use of a hand-held device that shows the participant their changes in
      heart rate based on changes in their breathing pattern (as they relax); caregivers who need
      or prefer the biofeedback will be given a device to use for 28 days. All study participants
      receiving the intervention will also be asked to keep a journal to record their experience
      with the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: A1) Caregiver health
time frame: 12 months
description: Examine differences across the four groups (control, usual care, SM-need, SM-preference) on caregiver health (health risks and mental and physical health) over time.
measure: A2) Caregiver baseline need / preference association
time frame: 12 months
description: Explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement.
measure: A3) Build caregiver profiles
time frame: 12 months
description: Build caregiver profiles from demographic / contextual factors that are associated with their needs and preferences for the self-management interventions.
arm group label: Self-management need
arm group type: Experimental
description: SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
arm group label: Self-management preference
arm group type: Experimental
description: SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
arm group label: Control
arm group type: No Intervention
description: No intervention or treatment
arm group label: Usual care
arm group type: Active Comparator
description: Bipolar education
intervention type: Behavioral
intervention name: Resourcefulness Training
description: A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
arm group label: Self-management need
arm group label: Self-management preference
intervention type: Behavioral
intervention name: Biofeedback training
description: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and continue to influence behavior.
arm group label: Self-management need
arm group label: Self-management preference
intervention type: Behavioral
intervention name: Bipolar Education
description: An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
arm group label: Self-management need
arm group label: Self-management preference
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Jaclene A. Zauszniewski
investigator title: Principal Investigator
sharing ipd: No
submitted: August 25, 2023