The Stronger at Home Study

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Other: Rehabilitation Program; Other: Conventional care; Other: Pain self management

• Registration Number: NCT04228068
• Lead Sponsor: Dr. Mohammad Auais, PhD

Brief Summary

Hip fracture is a major health problem facing older adults. Hip fractures result in higher mortality, morbidity, and costs than all other osteoporotic fractures combined. When returning home following hip fracture surgery, patients are at high risk of adverse outcomes (e.g., secondary fractures, institutionalisation, and death).

Objectives: This study aims to finalize and pilot test a new program of care including a user-friendly toolkit containing a home-based physiotherapy exercise and pain management program to help community-dwelling older adults recover after hip fractures.

Methods: This study will be two stages: First, finalizing the program. The investigators have created a self-explanatory toolkit that includes an illustrated exercise program based on a critical analysis of previous programs for hip fracture patients. The investigators will organize focus groups and conduct semi-structured interviews with patients, caregivers, policymakers, and healthcare providers to review the program and provide feedback.

Second, conducting a feasibility study. The investigators will pilot the program in a randomized trial with community-dwelling hip fracture patients and compare the intervention with conventional care.

Expected Outcomes: While the number of hip fracture survivors is increasing, they are becoming frailer, and their functional recovery has not improved, making this study timely and relevant. With the current focus on helping older adults "age in place," the proposed project addresses a vital health system challenge: helping older hip fracture patients access proper rehabilitation, so they can stay independent in their homes.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Primary Completion: 2020-03-30
• Study Completion: 2020-12-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• hip fracture patients who are 65 years or older
• being discharged to home or retirement home .

Exclusion Criteria

• participants with a terminal illness or significant contraindications preventing exercising (e.g. rapidly progressing neurological disease),
• live away more than 30 km from the centre of the city, and
• cannot sign the consent form and no proxy available to sign.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Rehabilitation Program	The exercise program will be for the first 12 weeks after returning home. The intervention will be provided after patients return home. Each patient will receive 7 home visits in total over the intervention period by a physiotherapist (PT) and/or a physiotherapy assistant (PTA). Participants in the intervention group will receive a copy of the Toolkit before discharge from the hospital, and the study coordinator will walk them through it and explain what should be expected during the intervention period.
Intervention	Pain self management	The exercise program will be for the first 12 weeks after returning home. The intervention will be provided after patients return home. Each patient will receive 7 home visits in total over the intervention period by a physiotherapist (PT) and/or a physiotherapy assistant (PTA). Participants in the intervention group will receive a copy of the Toolkit before discharge from the hospital, and the study coordinator will walk them through it and explain what should be expected during the intervention period.
Conventional care	Conventional care	Usual care

Primary Outcome Measures

Name	Time	Method
Change in the Lower Extremity Functional Scale (LEFS)	Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)	The Lower Extremity Functional Scale is a patient-reported outcome measure that consists of 20 items. psychometric properties have been tested and established for different populations including patients after hip surgeries and lower extremity conditions. Score range is 0-80 with higher scores indicating better function.

Secondary Outcome Measures

Name	Time	Method
The Short Physical Performance Battery (SPPB)	Change from baseline (before discharge), to 12 weeks weeks post discharge to home	The SPPB uses three tests to examine lower extremity physical performance: standing balance, gait speed, and chair-rising tests, and the total score is the sum of the three tests (0-12), with higher scores reflecting better physical function.

Trial Locations

Locations (1)

Providence Care Hospital; 🇨🇦 Kingston, Ontario, Canada