<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/NCT03814928</url>
  </required_header>
  <id_info>
    <org_study_id>H18-01409</org_study_id>
    <nct_id>NCT03814928</nct_id>
  </id_info>
  <brief_title>Caregivers' eCourse for Recovery After Hip Fracture</brief_title>
  <official_title>Recovery After Hip Fracture: A Novel Online Intervention for Caregivers</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>
      This project will test feasibility to deliver an online education and skill development&#xD;
      program for family/caregivers of older adults recovering from a surgically repaired&#xD;
      low-trauma hip fracture. We will also recruit health providers to review and provide feedback&#xD;
      on the eCourse before we test its feasibility and acceptability with caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional mixed methods study to obtain feedback from health providers and&#xD;
      family caregivers on eCourse for the post-hip fracture period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 1, 2022</start_date>
  <completion_date type="Anticipated">November 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</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>
    <intervention_model_description>feasibility study with health providers and family caregivers</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>eCourse Acceptability</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will be asked to rate (using a Likert scale 1 to 10) perceptions of acceptability of the (1) delivery mode and (2) program. All three questions are rate from 1 (lowest) - 10 (highest). A higher score is better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>eCourse Feasibility</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will be asked to rate (using a Likert scale 1 to 10) perceptions of feasibility of the (1) delivery mode and (2) program. All three questions are rate from 1 (lowest) - 10 (highest). A higher score is better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>eCourse Satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>We will ask people to rate their satisfaction with the eCourse [1 (not satisfied) to 10 (very satisfied)]. The higher the score the better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>eCourse Usefulness</measure>
    <time_frame>Day 1</time_frame>
    <description>We will ask people to rate their perception of the usefulness for the eCourse [1 (not useful) to 10 (very useful)]. The higher the score the better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Computer Self-Efficacy Scale</measure>
    <time_frame>Day 1</time_frame>
    <description>Questionnaires will assess participants' perceptions of self-efficacy (Modified Computer Self-Efficacy Scale) for using a computer and the online program. Scale of 1-10, 1 (not at all confident) - 10 (completely confident). The higher the score the better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unified Theory of Acceptance and Use of Technology 2</measure>
    <time_frame>Day 1</time_frame>
    <description>Questionnaires will assess participants' perceptions on technology usability (Unified Theory of Acceptance and Use of Technology 2). Participants will rate on a scale of 1-5, how much they disagree/agree with statements. 1 (strongly disagree) - 5 (strongly agree)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregivers' eCourse semi-structured interviews</measure>
    <time_frame>Day 1</time_frame>
    <description>We will conduct semi-structured interviews with caregivers to further explore perceptions and experience with eCourse and caregiving after hip fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregiver Strain Index</measure>
    <time_frame>Day 1</time_frame>
    <description>Ten questions on factors affected by caregiving with a yes or no response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ5D-5L (health-related quality of life)</measure>
    <time_frame>Day 1</time_frame>
    <description>Five domains of questions with five responses each. Calculate an index of 0 (lowest) - 1 (highest). There is also a Visual Analogue Scale [1 (worse health) - 100 (best health)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICECAP-O (general quality of life)</measure>
    <time_frame>Day 1</time_frame>
    <description>Five domains of questions with four responses each. Calculate an index of 0 (lowest) - 1 (highest).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Family</condition>
  <arm_group>
    <arm_group_label>Caregivers eCourse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Education post-hip fracture delivered via eCourse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caregivers eCourse</intervention_name>
    <description>Investigators will request that family/caregivers watch a self-paced (60-90 minutes) online e-learning training session for recovery after hip fracture.</description>
    <arm_group_label>Caregivers eCourse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family/caregivers of older adults with hip fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults less than 19 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UBC</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</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>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>education</keyword>
  <keyword>caregivers</keyword>
  <keyword>eCourse</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Investigators will ask participants' permission to share anonymized data in the consent form, but they can choose to opt out.</ipd_description>
  </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/NCT03814928
org study id: H18-01409
nct id: NCT03814928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project will test feasibility to deliver an online education and skill development
      program for family/caregivers of older adults recovering from a surgically repaired
      low-trauma hip fracture. We will also recruit health providers to review and provide feedback
      on the eCourse before we test its feasibility and acceptability with caregivers.
This is a cross-sectional mixed methods study to obtain feedback from health providers and
      family caregivers on eCourse for the post-hip fracture period.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: feasibility study with health providers and family caregivers
primary purpose: Other
masking: None (Open Label)
measure: eCourse Acceptability
time frame: Day 1
description: Participants will be asked to rate (using a Likert scale 1 to 10) perceptions of acceptability of the (1) delivery mode and (2) program. All three questions are rate from 1 (lowest) - 10 (highest). A higher score is better.
measure: eCourse Feasibility
time frame: Day 1
description: Participants will be asked to rate (using a Likert scale 1 to 10) perceptions of feasibility of the (1) delivery mode and (2) program. All three questions are rate from 1 (lowest) - 10 (highest). A higher score is better.
measure: eCourse Satisfaction
time frame: Day 1
description: We will ask people to rate their satisfaction with the eCourse [1 (not satisfied) to 10 (very satisfied)]. The higher the score the better.
measure: eCourse Usefulness
time frame: Day 1
description: We will ask people to rate their perception of the usefulness for the eCourse [1 (not useful) to 10 (very useful)]. The higher the score the better.
measure: Modified Computer Self-Efficacy Scale
time frame: Day 1
description: Questionnaires will assess participants' perceptions of self-efficacy (Modified Computer Self-Efficacy Scale) for using a computer and the online program. Scale of 1-10, 1 (not at all confident) - 10 (completely confident). The higher the score the better.
measure: Unified Theory of Acceptance and Use of Technology 2
time frame: Day 1
description: Questionnaires will assess participants' perceptions on technology usability (Unified Theory of Acceptance and Use of Technology 2). Participants will rate on a scale of 1-5, how much they disagree/agree with statements. 1 (strongly disagree) - 5 (strongly agree)
measure: Caregivers' eCourse semi-structured interviews
time frame: Day 1
description: We will conduct semi-structured interviews with caregivers to further explore perceptions and experience with eCourse and caregiving after hip fracture.
measure: Caregiver Strain Index
time frame: Day 1
description: Ten questions on factors affected by caregiving with a yes or no response.
measure: EQ5D-5L (health-related quality of life)
time frame: Day 1
description: Five domains of questions with five responses each. Calculate an index of 0 (lowest) - 1 (highest). There is also a Visual Analogue Scale [1 (worse health) - 100 (best health)]
measure: ICECAP-O (general quality of life)
time frame: Day 1
description: Five domains of questions with four responses each. Calculate an index of 0 (lowest) - 1 (highest).
arm group label: Caregivers eCourse
arm group type: Experimental
description: Education post-hip fracture delivered via eCourse.
intervention type: Behavioral
intervention name: Caregivers eCourse
description: Investigators will request that family/caregivers watch a self-paced (60-90 minutes) online e-learning training session for recovery after hip fracture.
arm group label: Caregivers eCourse
criteria: 
gender: All
minimum age: 19 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: Associate Professor
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: Undecided
ipd description: Investigators will ask participants' permission to share anonymized data in the consent form, but they can choose to opt out.