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Completed

NCT Number: NCT01930409

Back to the Future: Bridging the Hospital to Home Continuum 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.

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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Support and Coaching

Behavioral

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

Education only

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture

Acronym: B2F

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 28, 2013
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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