The Stronger at Home Study

NCT04228068 | Completed

• 1 other identifier: REH-721-18
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Change in the Lower Extremity Functional Scale (LEFS)

  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.

  Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)

Secondary Outcomes (1)

• The Short Physical Performance Battery (SPPB)

  Change from baseline (before discharge), to 12 weeks weeks post discharge to home

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Rehabilitation Program; Other: Pain self management

Conventional care

ACTIVE COMPARATOR

Usual care

Other: Conventional care

Interventions

Rehabilitation Program 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.

Intervention

Pain self management 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.

Intervention

Conventional care OTHER

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

Conventional care

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Mohammad Auais, PhD: lead

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7M 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 36070134 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 14, 2020
• Study Start: March 15, 2018
• Primary Completion: March 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)