- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814928
Caregivers' eCourse for Recovery After Hip Fracture
November 2, 2023 updated by: Maureen C. Ashe, University of British Columbia
Recovery After Hip Fracture: A Novel Online Intervention for Caregivers
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
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.
For participants who access the course via the PI's website, participants will only be asked to provide feedback on the content and layout of the eCourse.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vancouver, Canada
- UBC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Family/caregivers of older adults with hip fracture, or general public (for website recruitment)
Exclusion Criteria:
- Adults less than 19 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caregivers eCourse
Education post-hip fracture delivered via eCourse.
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Investigators will request that family/caregivers/general public watch a self-paced (60-90 minutes) online e-learning training session for recovery after hip fracture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
eCourse Feasibility
Time Frame: Day 1
|
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.
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Day 1
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eCourse Satisfaction
Time Frame: Day 1
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We will ask people to rate their satisfaction with the eCourse [1 (not satisfied) to 10 (very satisfied)].
The higher the score the better.
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Day 1
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eCourse Usefulness
Time Frame: Day 1
|
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.
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Day 1
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Modified Computer Self-Efficacy Scale
Time Frame: Day 1
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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.
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Day 1
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Unified Theory of Acceptance and Use of Technology 2
Time Frame: Day 1
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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)
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Day 1
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Caregivers' eCourse semi-structured interviews
Time Frame: Day 1
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We will conduct semi-structured interviews with caregivers to further explore perceptions and experience with eCourse and caregiving after hip fracture.
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Day 1
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eCourse Acceptibility
Time Frame: Day 1
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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.
|
Day 1
|
Feedback on eCourse for participants who enrol via the PI's website: PEMAT
Time Frame: Day 1
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Patient Education Materials Assessment Tool (PEMAT) to evaluate the understandability and actionability of the material in our eCourse.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Strain Index
Time Frame: Day 1
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Ten questions on factors affected by caregiving with a yes or no response.
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Day 1
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EQ5D-5L (health-related quality of life)
Time Frame: Day 1
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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)]
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Day 1
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ICECAP-O (general quality of life)
Time Frame: Day 1
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Five domains of questions with four responses each.
Calculate an index of 0 (lowest) - 1 (highest).
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
January 18, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-01409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Investigators will ask participants' permission to share anonymized data in the consent form, but they can choose to opt out.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
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Smith & Nephew, Inc.Terminated
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Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
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Carilion ClinicCompleted
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FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
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Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
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Bayside HealthCompleted
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Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
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Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
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University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
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Rabin Medical CenterUnknown
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