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Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture (B2F)

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone Support and Coaching
Education Only
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Femoral Fractures, Hip Fractures, Frail older adults, Quality of Life, Feasibility Studies

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lions Gate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education Only

Education + Telephone Follow-up

Arm Description

A 1 hour education session in the acute setting A toolkit with education, exercise and self management instructions for after hip fracture

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.

Outcomes

Primary Outcome Measures

Feasibility of study recruitment and retention
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2013
Last Updated
October 25, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01930409
Brief Title
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture
Acronym
B2F
Official Title
A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Femoral Fractures, Hip Fractures, Frail older adults, Quality of Life, Feasibility Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education Only
Arm Type
Active Comparator
Arm Description
A 1 hour education session in the acute setting A toolkit with education, exercise and self management instructions for after hip fracture
Arm Title
Education + Telephone Follow-up
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Support and Coaching
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Education Only
Intervention Description
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
Primary Outcome Measure Information:
Title
Feasibility of study recruitment and retention
Description
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life EQ5D-5L
Description
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.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Quality of Life ICECAP-O
Time Frame
4 months
Title
de Morton Mobility Index (DEMMI)
Description
The DEMMI is a clinical instrument for measuring mobility in older adults. Interval levels are obtained from 0 (poor mobility) to 100 (excellent mobility)
Time Frame
4 months
Title
Gait (Walking) speed
Description
Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
Time Frame
4 months
Title
Falls FES-1
Description
Falls self efficacy questionnaire will be used.
Time Frame
4 months
Title
Pain: Visual Analogue Scale (VAS)
Time Frame
4 months
Title
Falls self report diary
Description
Participants will record Falls in a check box format daily
Time Frame
4 months
Title
The Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores P Langford, Msc.
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen C Ashe, PhD
Organizational Affiliation
Centre for Hip Health and Mobility
Official's Role
Study Director
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7L 2L7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture

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