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

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
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital

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

  • 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

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.

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

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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