Hip FractureB2FNCT01930409
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture
A study testing Telephone Support and Coaching and Education Only in people with Hip Fracture, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Telephone Support and Coaching and Education Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (men and women) over 60 years of age
- Fall related hip fracture
- Community dwelling
- English speaking
Who cannot join
- Dementia
- Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
- Profound hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fracture
- Being tested
- Telephone Support and Coaching, Education Only
- Keywords
- Femoral Fractures, Hip Fractures, Frail older adults, Quality of Life, Feasibility Studies
- Medical subject headings
- Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Support and CoachingBehavioural
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:
- Health Status
- Medication Management
- Activity/Exercise Prescription and Goal-Setting
- Falls Prevention
- Clarification of Appointments
- Coordination of Post-Discharge Home Services
- What To Do If a Problem Arises
Education OnlyBehavioural
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
| Study group | Role | What they receive |
|---|---|---|
| Education Only | Active comparator | * A 1 hour education session in the acute setting
* A toolkit with education, exercise and self management instructions for after hip fracture Receives: Behavioral: Education Only |
| Education + Telephone Follow-up | Experimental | * A 1 hour education session in the acute setting
* A telephone delivered self management program , including a toolkit (education, exercise and self management instructions for after hip fracture), support to take an active role in recovery, including setting and monitoring goals, problem solving mobility barriers, and guidance on the recovery process following a hip fracture. Receives: Behavioral: Telephone Support and Coaching; Behavioral: Education Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment and retention
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
Measured: 1 year
Secondary outcomes (1)
Quality of Life EQ5D-5L
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dolores Langford, University of British Columbia
- Investigators
- Dolores P Langford, Msc., Principal investigator, Vancouver Coastal HealthMaureen C Ashe, PhD, Study director, Centre for Hip Health and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930409
- Sponsor's protocol ID
- H13-01810
- Acronym
- B2F
- Status last verified
- Oct 2017
- First submitted
- 31 Jul 2013
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture
- ClinicalTrials.gov ID
- NCT01930409
- Acronym / sponsor ID
- B2F / H13-01810
- Conditions
- Hip Fracture
- Keywords
- Femoral Fractures, Hip Fractures, Frail older adults, Quality of Life, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Only | Active comparator | Behavioral: Education Only* A 1 hour education session in the acute setting * A toolkit with education, exercise and self management instructions for after hip fracture |
| Education + Telephone Follow-up | Experimental | Behavioral: Telephone Support and Coaching, Behavioral: Education Only* A 1 hour education session in the acute setting * A telephone delivered self management program , including a toolkit (education, exercise and self management instructions for after hip fracture), support to take an active role in recovery, including setting and monitoring goals, problem solving mobility barriers, and guidance on the recovery process following a hip fracture. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (men and women) over 60 years of age
- Fall related hip fracture
- Community dwelling
- English speaking
Key exclusion criteria (3 listed)
- Dementia
- Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
- Profound hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Support and CoachingThe 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: * Health Status * Medication Management * Activity/Exercise Prescription and Goal-Setting * Falls Prevention * Clarification of Appointments * Coordination of Post-Discharge Home Services * What To Do If a Problem Arises | Behavioural | Education + Telephone Follow-up |
| Education OnlyAn educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture | Behavioural | Education + Telephone Follow-up, Education Only |
Primary outcome
Feasibility of study recruitment and retention
Time frame: 1 year
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
1 secondary outcome
Quality of Life EQ5D-5L
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolores P Langford, Msc. principal investigator
Vancouver Coastal Health
Maureen C Ashe, PhD study director
Centre for Hip Health and Mobility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Support and Coaching and Education Only in people with Hip Fracture, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study recruitment and retention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.