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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01930409
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Dolores Langford, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hip Fracture Behavioral: Telephone Support and Coaching Behavioral: Education Only Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Behavioral: 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
  • 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.
 Behavioral: Telephone Support and Coaching

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

Behavioral: Education Only
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of study recruitment and retention [ Time Frame: 1 year ]
    Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Quality of Life ICECAP-O [ Time Frame: 4 months ]
  2. 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)

  3. Gait (Walking) speed [ Time Frame: 4 months ]
    Gait speed is a reliable, valid and sensitive measure likened to a vital sign.

  4. Falls FES-1 [ Time Frame: 4 months ]
    Falls self efficacy questionnaire will be used.

  5. Pain: Visual Analogue Scale (VAS) [ Time Frame: 4 months ]
  6. Falls self report diary [ Time Frame: 4 months ]
    Participants will record Falls in a check box format daily

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930409


Locations
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Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Dolores P Langford, Msc. Vancouver Coastal Health
Study Director: Maureen C Ashe, PhD Centre for Hip Health and Mobility
More Information
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Responsible Party: Dolores Langford, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01930409    
Other Study ID Numbers: H13-01810
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Dolores Langford, University of British Columbia:
Femoral Fractures
Hip Fractures
Frail older adults
Quality of Life
Feasibility Studies
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries