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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930409
Other study ID # H13-01810
Secondary ID
Status Completed
Phase N/A
First received July 31, 2013
Last updated October 25, 2017
Start date November 2013
Est. completion date January 2015

Study information

Verified date October 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 60 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Lions Gate Hospital North Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life ICECAP-O 4 months
Other de Morton Mobility Index (DEMMI) The DEMMI is a clinical instrument for measuring mobility in older adults. Interval levels are obtained from 0 (poor mobility) to 100 (excellent mobility) 4 months
Other Gait (Walking) speed Gait speed is a reliable, valid and sensitive measure likened to a vital sign. 4 months
Other Falls FES-1 Falls self efficacy questionnaire will be used. 4 months
Other Pain: Visual Analogue Scale (VAS) 4 months
Other Falls self report diary Participants will record Falls in a check box format daily 4 months
Other The Hospital Anxiety and Depression Scale (HADS) The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression 4 months
Primary Feasibility of study recruitment and retention Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition) 1 year
Secondary Quality of Life EQ5D-5L 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. 4 months
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