- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930409
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture (B2F)
October 25, 2017 updated by: Dolores Langford, University of British Columbia
A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture
The purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture.
The primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults.
In parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.
Study Type
Interventional
Enrollment (Anticipated)
30
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
-
-
British Columbia
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North Vancouver, British Columbia, Canada, V7L 2L7
- Lions Gate Hospital
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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
60 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults (men and women) over 60 years of age
- Fall related hip fracture
- Community dwelling
- English speaking
Exclusion Criteria:
- Dementia
- Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
- Profound hearing loss
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Education Only
|
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
|
|
Experimental: Education + Telephone Follow-up
|
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
The participants will receive up to 5 telephone calls of 30-45 minutes each after hospital discharge to provide support and education for the transition from acute to community care. The first call will be made within 48-72 hours of hospital discharge and will have the following elements:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of study recruitment and retention
Time Frame: 1 year
|
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life EQ5D-5L
Time Frame: 4 months
|
The EQ5D-5L Quality of Life outcome measure is a self reported questionnaire measure, and has been extensively investigated in the hip fracture population, with well established sensitivity, reliability and validity properties.
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life ICECAP-O
Time Frame: 4 months
|
4 months
|
|
|
de Morton Mobility Index (DEMMI)
Time Frame: 4 months
|
The DEMMI is a clinical instrument for measuring mobility in older adults.
Interval levels are obtained from 0 (poor mobility) to 100 (excellent mobility)
|
4 months
|
|
Gait (Walking) speed
Time Frame: 4 months
|
Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
|
4 months
|
|
Falls FES-1
Time Frame: 4 months
|
Falls self efficacy questionnaire will be used.
|
4 months
|
|
Pain: Visual Analogue Scale (VAS)
Time Frame: 4 months
|
4 months
|
|
|
Falls self report diary
Time Frame: 4 months
|
Participants will record Falls in a check box format daily
|
4 months
|
|
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 months
|
The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dolores P Langford, Msc., Vancouver Coastal Health
- Study Director: Maureen C Ashe, PhD, Centre for Hip Health and Mobility
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
November 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
July 31, 2013
First Submitted That Met QC Criteria
August 23, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-01810
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.
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