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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930409
First Posted: August 28, 2013
Last Update Posted: October 27, 2017
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.
Information provided by (Responsible Party):
Dolores Langford, University of British Columbia
July 31, 2013
August 28, 2013
October 27, 2017
November 2013
September 2014   (Final data collection date for primary outcome measure)
Feasibility of study recruitment and retention [ Time Frame: 1 year ]
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
Same as current
Complete list of historical versions of study NCT01930409 on ClinicalTrials.gov Archive Site
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.
Same as current
  • Quality of Life ICECAP-O [ Time Frame: 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)
  • Gait (Walking) speed [ Time Frame: 4 months ]
    Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
  • Falls FES-1 [ Time Frame: 4 months ]
    Falls self efficacy questionnaire will be used.
  • Pain: Visual Analogue Scale (VAS) [ Time Frame: 4 months ]
  • Falls self report diary [ Time Frame: 4 months ]
    Participants will record Falls in a check box format daily
  • 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
  • Quality of Life ICECAP-O [ Time Frame: 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)
  • Gait (Walking) speed [ Time Frame: 4 months ]
    Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
  • Falls FES-1 [ Time Frame: 4 months ]
    Falls self efficacy questionnaire will be used.
  • Pain: Visual Analogue Scale (VAS) [ Time Frame: 4 months ]
  • Falls self report diary [ Time Frame: 4 months ]
    Partiicpants will record Falls in a check box format daily
  • 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
 
Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
  • 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
    Intervention: Behavioral: Education Only
  • 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.
    Interventions:
    • Behavioral: Telephone Support and Coaching
    • Behavioral: Education Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2015
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01930409
H13-01810
Yes
Not Provided
Not Provided
Dolores Langford, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Dolores P Langford, Msc. Vancouver Coastal Health
Study Director: Maureen C Ashe, PhD Centre for Hip Health and Mobility
University of British Columbia
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP