<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/NCT02205671</url>
  </required_header>
  <id_info>
    <org_study_id>29894</org_study_id>
    <nct_id>NCT02205671</nct_id>
  </id_info>
  <brief_title>Building Better Caregivers: Development and Evaluation</brief_title>
  <official_title>Building Better Caregivers: Development and Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The program consists of a 6-week small-group workshop for caregivers of people with memory&#xD;
      problems.&#xD;
&#xD;
      The goal of the study is to evaluate in a one year longitudinal study, program effectiveness&#xD;
      in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving&#xD;
      sleep, healthful behaviors and self-efficacy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small&#xD;
      groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a&#xD;
      2-day cross-training before leading a BBC workshop).&#xD;
&#xD;
      Participants will learn self-management skills such as decision making, goal setting, action&#xD;
      planning, stress management, dealing with difficult behaviors, working with the health care&#xD;
      system, planning for the future,building an exercise program, communication skills, healthy&#xD;
      eating, etc.&#xD;
&#xD;
      All participants will complete follow up questionnaires and 6 and 12 months. They will have&#xD;
      the option of completing the questionnaire by mail or telephone interview.&#xD;
&#xD;
      Once a particular workshop site is identified by a partner organization, Stanford will&#xD;
      provide packets of consents and questionnaires to the site coordinator(non-Stanford). The&#xD;
      site coordinator will either schedule an extra hour for the first meeting of the 6-week&#xD;
      series, or an orientation meeting held a week or so before the workshop begins. During this&#xD;
      time, the coordinator will announce to the prospective subjects that this study is being&#xD;
      conducted and that they are invited to participate, and will pass out a consent,&#xD;
      questionnaire and consent copy to each prospective participant. The consent and questionnaire&#xD;
      are self-administered.&#xD;
&#xD;
      This study is longitudinal, so no randomization will take place.&#xD;
&#xD;
      Stanford holds no meetings, but receives the data. The site coordinators hold the orientation&#xD;
      meetings. The workshops are scheduled by the various organizations, and they determine when&#xD;
      and how the orientation time is scheduled. It will vary from site to site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>visual numeric 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>visual numeric 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stress</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>visual numeric 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>problems sleeping</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>visual numeric 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>depression (PHQ-8)</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>8 item 0-3 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>self-efficacy for caregiving</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>9-item 1-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>caregiver stress</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>13-item 3 point scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>caregiver burden</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>12-item 5 point scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>health care utilization (doctor, emergency department, hospital)</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>number of times/days in past 6 month visited doctor, emergency department, hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>exercise</measure>
    <time_frame>baseline- 1 year</time_frame>
    <description>number of minutes of exercise in past week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>general health</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>single item scale of overall health</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>care partner health utilization</measure>
    <time_frame>baseline- 1 year</time_frame>
    <description>number of MD ER hospital visits for person being cared for in past 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>carepartners general health</measure>
    <time_frame>baseline-1 year</time_frame>
    <description>single item scale of overall health of person being cared for</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Providing Care for People With Memory Problems</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Building Better Caregivers Small-group Workshop</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Building Better Caregivers Small-group Workshop</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family or friend caregiver of someone with cognitive impairment for at least 10 hours&#xD;
             per week&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to attend a workshop 2.5 hours per week for 6 weeks&#xD;
&#xD;
          -  Speaks English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Professional caregiver&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate Lorig, DRPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Kate Lorig</investigator_full_name>
    <investigator_title>Professor Emeritus</investigator_title>
  </responsible_party>
  <keyword>caregiving</keyword>
  <keyword>chronic illness</keyword>
  <keyword>patient education</keyword>
  <keyword>self management</keyword>
  <!-- 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/NCT02205671
org study id: 29894
nct id: NCT02205671
lead sponsor: 
has dmc: No
The program consists of a 6-week small-group workshop for caregivers of people with memory
      problems.

      The goal of the study is to evaluate in a one year longitudinal study, program effectiveness
      in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving
      sleep, healthful behaviors and self-efficacy
The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small
      groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a
      2-day cross-training before leading a BBC workshop).

      Participants will learn self-management skills such as decision making, goal setting, action
      planning, stress management, dealing with difficult behaviors, working with the health care
      system, planning for the future,building an exercise program, communication skills, healthy
      eating, etc.

      All participants will complete follow up questionnaires and 6 and 12 months. They will have
      the option of completing the questionnaire by mail or telephone interview.

      Once a particular workshop site is identified by a partner organization, Stanford will
      provide packets of consents and questionnaires to the site coordinator(non-Stanford). The
      site coordinator will either schedule an extra hour for the first meeting of the 6-week
      series, or an orientation meeting held a week or so before the workshop begins. During this
      time, the coordinator will announce to the prospective subjects that this study is being
      conducted and that they are invited to participate, and will pass out a consent,
      questionnaire and consent copy to each prospective participant. The consent and questionnaire
      are self-administered.

      This study is longitudinal, so no randomization will take place.

      Stanford holds no meetings, but receives the data. The site coordinators hold the orientation
      meetings. The workshops are scheduled by the various organizations, and they determine when
      and how the orientation time is scheduled. It will vary from site to site.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fatigue
time frame: baseline-1 year
description: visual numeric 0-10 scale
measure: Pain
time frame: baseline-1 year
description: visual numeric 0-10 scale
measure: stress
time frame: baseline-1 year
description: visual numeric 0-10 scale
measure: problems sleeping
time frame: baseline-1 year
description: visual numeric 0-10 scale
measure: depression (PHQ-8)
time frame: baseline-1 year
description: 8 item 0-3 scale
measure: self-efficacy for caregiving
time frame: baseline-1 year
description: 9-item 1-10 scale
measure: caregiver stress
time frame: baseline-1 year
description: 13-item 3 point scale
measure: caregiver burden
time frame: baseline-1 year
description: 12-item 5 point scale
measure: health care utilization (doctor, emergency department, hospital)
time frame: baseline-1 year
description: number of times/days in past 6 month visited doctor, emergency department, hospital
measure: exercise
time frame: baseline- 1 year
description: number of minutes of exercise in past week
measure: general health
time frame: baseline-1 year
description: single item scale of overall health
measure: care partner health utilization
time frame: baseline- 1 year
description: number of MD ER hospital visits for person being cared for in past 6 months
measure: carepartners general health
time frame: baseline-1 year
description: single item scale of overall health of person being cared for
arm group label: Intervention
arm group type: Experimental
description: Building Better Caregivers Small-group Workshop
intervention type: Behavioral
intervention name: Building Better Caregivers Small-group Workshop
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kate Lorig, DRPH
role: Principal Investigator
affiliation: Stanford School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Kate Lorig
investigator title: Professor Emeritus