The Stronger at Home Study

NCT ID: NCT04228068

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Rehabilitation Program

Intervention Type OTHER

PT visits (two visits): The first visit will happen within a week of discharge. During this visit, the PT will assess participants, tailor the program to their needs, and coach them in carrying out the exercises at home. The last visit will be 12 weeks after the first. During this visit, the PT will reassess the participants and make adjustments to the program. The participants will be encouraged to continue exercising beyond the 12 weeks.

The PTA will visit the participants' homes with the PT and will conduct additional solo visits every other week (i.e. 7 PTA visits in total, in 1st week and at 2, 4, 6, 8, 10, and 12 weeks). The PTA will facilitate and progress the exercise program as prescribed and directed by the PT and help in delivering the education component of the program.

Pain self management

Intervention Type OTHER

In addition to the exercise program, the intervention group will receive a pain self-management support tailored by the PT to the participants' needs.

Conventional care

Usual care

Group Type ACTIVE_COMPARATOR

Conventional care

Intervention Type OTHER

The control group will receive the usual care provided by the healthcare system.

Interventions

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Rehabilitation Program

PT visits (two visits): The first visit will happen within a week of discharge. During this visit, the PT will assess participants, tailor the program to their needs, and coach them in carrying out the exercises at home. The last visit will be 12 weeks after the first. During this visit, the PT will reassess the participants and make adjustments to the program. The participants will be encouraged to continue exercising beyond the 12 weeks.

The PTA will visit the participants' homes with the PT and will conduct additional solo visits every other week (i.e. 7 PTA visits in total, in 1st week and at 2, 4, 6, 8, 10, and 12 weeks). The PTA will facilitate and progress the exercise program as prescribed and directed by the PT and help in delivering the education component of the program.

Intervention Type OTHER

Pain self management

In addition to the exercise program, the intervention group will receive a pain self-management support tailored by the PT to the participants' needs.

Intervention Type OTHER

Conventional care

The control group will receive the usual care provided by the healthcare system.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Mohammad Auais, PhD

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mohammad Auais, PhD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Providence Care Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.

Reference Type DERIVED
PMID: 36070134 (View on PubMed)

Other Identifiers

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REH-721-18

Identifier Type: -

Identifier Source: org_study_id