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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01930409
First received: July 31, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention
Hip Fracture
Behavioral: Telephone Support and Coaching
Behavioral: Education Only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Feasibility of study recruitment and retention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)


Secondary Outcome Measures:
  • Quality of Life EQ5D-5L [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • Quality of Life ICECAP-O [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • de Morton Mobility Index (DEMMI) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Gait speed is a reliable, valid and sensitive measure likened to a vital sign.

  • Falls FES-1 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Falls self efficacy questionnaire will be used.

  • Pain: Visual Analogue Scale (VAS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Falls self report diary [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Participants will record Falls in a check box format daily

  • The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930409

Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dolores P Langford, Msc. Vancouver Coastal Health
Study Director: Maureen C Ashe, PhD Centre for Hip Health and Mobility
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01930409     History of Changes
Other Study ID Numbers: H13-01810
Study First Received: July 31, 2013
Last Updated: June 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Femoral Fractures
Hip Fractures
Frail older adults
Quality of Life
Feasibility Studies

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014