The Stronger at Home Study
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rehabilitation Program
Pain self management
Conventional care
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
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.
Sites / Locations
- Providence Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Conventional care
Arm Description
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.
Usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The Short Physical Performance Battery (SPPB)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04228068
Brief Title
The Stronger at Home Study
Official Title
A Home-Based Rehabilitation Program for Patients With Hip Fracture: A Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional care
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Rehabilitation Program
Intervention Description
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
Intervention Name(s)
Pain self management
Intervention Description
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
Intervention Name(s)
Conventional care
Intervention Description
The control group will receive the usual care provided by the healthcare system.
Primary Outcome Measure Information:
Title
Change in the Lower Extremity Functional Scale (LEFS)
Description
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.
Time Frame
Change from baseline (before discharge) to 12 weeks post discharge to home (post intervention)
Secondary Outcome Measure Information:
Title
The Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
Change from baseline (before discharge), to 12 weeks weeks post discharge to home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Providence Care Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7M 3N6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36070134
Citation
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.
Results Reference
derived
Learn more about this trial
The Stronger at Home Study
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