NCT01930409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

July 31, 2013

Last Update Submit

October 25, 2017

Conditions

Keywords

Femoral FracturesHip FracturesFrail older adultsQuality of LifeFeasibility Studies

Outcome Measures

Primary Outcomes (1)

  • Feasibility of study recruitment and retention

    Feasibility will be measured by recruitment rate (30%), and retention rate (\<10% attrition)

    1 year

Secondary Outcomes (1)

  • Quality of Life EQ5D-5L

    4 months

Other Outcomes (7)

  • Quality of Life ICECAP-O

    4 months

  • de Morton Mobility Index (DEMMI)

    4 months

  • Gait (Walking) speed

    4 months

  • +4 more other outcomes

Study Arms (2)

Education Only

ACTIVE COMPARATOR

* 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

Education + Telephone Follow-up

EXPERIMENTAL

* 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 CoachingBehavioral: Education Only

Interventions

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 + Telephone Follow-up
Education OnlyBEHAVIORAL

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

Education + Telephone Follow-upEducation Only

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (men and women) over 60 years of age
  • Fall related hip fracture
  • Community dwelling
  • English speaking

You may not qualify if:

  • Dementia
  • Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
  • Profound hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

MeSH Terms

Conditions

Hip FracturesFemoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Dolores P Langford, Msc.

    Vancouver Coastal Health

    PRINCIPAL INVESTIGATOR
  • Maureen C Ashe, PhD

    Centre for Hip Health and Mobility

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 28, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations