<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/NCT04467814</url>
  </required_header>
  <id_info>
    <org_study_id>H20-01612</org_study_id>
    <nct_id>NCT04467814</nct_id>
  </id_info>
  <brief_title>Better Together: Reablement and Caregivers</brief_title>
  <acronym>B2G</acronym>
  <official_title>Out and About: Reablement for Older Adults in the Hospital Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</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>
      Hospitalization creates opportunities for older adults to accumulate prolonged periods of&#xD;
      sitting and lying (defined as sedentary behavior) which can result in mobility loss. We&#xD;
      propose a Type 1 Hybrid Effectiveness-Implementation Trial with 1:1 randomization to test the&#xD;
      effect of a caregiver intervention on older patients' physical activity at 3 months (home).&#xD;
      We will recruit 61 patients and family caregivers from hospital units and follow them for 3&#xD;
      months; the primary outcome is patients' daily step count at 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to COVID-related issues had to change study design.&#xD;
  </why_stopped>
  <start_date type="Actual">April 26, 2023</start_date>
  <completion_date type="Actual">April 26, 2023</completion_date>
  <primary_completion_date type="Actual">April 26, 2023</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Veterans Rand-12 Quality of Life</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>12 item quality of life survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily minutes sedentary behavior</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>daily minutes of sedentary behavior measured with an activity monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily minutes of physical activity</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>daily minutes of physical activity measured with an activity monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment with Chronic Illness Care Survey</measure>
    <time_frame>3 months</time_frame>
    <description>20-item survey with questions related to experience with hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Action Planning (BAP)</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Goal setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Plans behaviors</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping Plans</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Intentions</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Self-efficacy</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Risk Perceptions</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Outcome Expectancies</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Habit Index</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-reported health behavior questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program implementation</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>Semi-structured interviews or focus groups with patients, caregivers, and heath providers to understand factors related program implementation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Steps per day</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>activity monitor</description>
  </other_outcome>
  <other_outcome>
    <measure>Falls</measure>
    <time_frame>baseline to 3 months</time_frame>
    <description>monthly falls diary</description>
  </other_outcome>
  <other_outcome>
    <measure>Falls Efficacy Scale International (FES-I)</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>16 questions related to falls self-efficacy. Scoring: minimum 16 (no falling concerns) to maximum 64 (high falling concern)</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Test of Adult Cognition by Telephone</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>cognitive test</description>
  </other_outcome>
  <other_outcome>
    <measure>Unified Theory of Acceptance and Use of Technology 2 Survey</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>self-report questions on perceptions of using technology</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Older Adults</condition>
  <condition>Sedentary Behavior</condition>
  <condition>Physical Activity</condition>
  <condition>Caregiver</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Better Together</intervention_name>
    <description>Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.&#xD;
Caregiver participants in the intervention group will receive up to six telephone or video calls with the research assistant or Clinical Resource Therapist. Sessions will review the knowledge translation (KT) product with family members (~15 minutes), art goals, brainstorm strategies, and discuss setbacks. The calls with the caregiver may occur 1 to 2 times in the hospital, within one week of going home, and then in Months 2 and 3.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Older adults (60 years and older) with a recent hospitalization and&#xD;
        their caregiver.&#xD;
&#xD;
        Exclusion Criteria: Caregivers and older adults with a dementia diagnosis, head injury,&#xD;
        significant neurological impairment, or receive treatment for medical conditions that&#xD;
        preclude exercising.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Maureen C. Ashe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>caregiver, patient, e-Course</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04467814
org study id: H20-01612
nct id: NCT04467814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hospitalization creates opportunities for older adults to accumulate prolonged periods of
      sitting and lying (defined as sedentary behavior) which can result in mobility loss. We
      propose a Type 1 Hybrid Effectiveness-Implementation Trial with 1:1 randomization to test the
      effect of a caregiver intervention on older patients' physical activity at 3 months (home).
      We will recruit 61 patients and family caregivers from hospital units and follow them for 3
      months; the primary outcome is patients' daily step count at 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Veterans Rand-12 Quality of Life
time frame: baseline and 3 months
description: 12 item quality of life survey
measure: Daily minutes sedentary behavior
time frame: baseline to 3 months
description: daily minutes of sedentary behavior measured with an activity monitor
measure: Daily minutes of physical activity
time frame: baseline to 3 months
description: daily minutes of physical activity measured with an activity monitor
measure: Patient Assessment with Chronic Illness Care Survey
time frame: 3 months
description: 20-item survey with questions related to experience with hospitalization.
measure: Brief Action Planning (BAP)
time frame: baseline and 3 months
description: Goal setting
measure: Action Plans behaviors
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Coping Plans
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Physical Activity Intentions
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Physical Activity Self-efficacy
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Physical Activity Risk Perceptions
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Physical Activity Outcome Expectancies
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Self-reported Habit Index
time frame: baseline and 3 months
description: self-reported health behavior questions
measure: Program implementation
time frame: baseline and 3 months
description: Semi-structured interviews or focus groups with patients, caregivers, and heath providers to understand factors related program implementation.
measure: Steps per day
time frame: baseline to 3 months
description: activity monitor
measure: Falls
time frame: baseline to 3 months
description: monthly falls diary
measure: Falls Efficacy Scale International (FES-I)
time frame: baseline and 3 months
description: 16 questions related to falls self-efficacy. Scoring: minimum 16 (no falling concerns) to maximum 64 (high falling concern)
measure: Brief Test of Adult Cognition by Telephone
time frame: baseline and 3 months
description: cognitive test
measure: Unified Theory of Acceptance and Use of Technology 2 Survey
time frame: baseline and 3 months
description: self-report questions on perceptions of using technology
arm group label: Intervention
arm group type: Experimental
arm group label: Usual Care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Better Together
description: Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.
Caregiver participants in the intervention group will receive up to six telephone or video calls with the research assistant or Clinical Resource Therapist. Sessions will review the knowledge translation (KT) product with family members (~15 minutes), art goals, brainstorm strategies, and discuss setbacks. The calls with the caregiver may occur 1 to 2 times in the hospital, within one week of going home, and then in Months 2 and 3.
arm group label: Intervention
intervention type: Behavioral
intervention name: Usual Care
description: Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Maureen C. Ashe
investigator title: Principal Investigator
sharing ipd: No