Stronger At Home: Improving Outcomes for Older Adults After Hip Fracture
NCT ID: NCT05972005
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-17
2028-07-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main question this trial aims to answer are:
• Is the Stronger at Home program more effective than usual care in improving functional recovery at the end of the 14-week intervention?
secondary questions include:
* What is the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge?
* Does the program have a sustained impact on functional recovery at 6 months and 12 months post-discharge?
Participants in the trial will be asked to engage in the following tasks:
* Participate in the Stronger at Home program, which includes using a self-directed toolkit consisting of educational resources and an illustrated exercise program.
* Follow the guidelines provided in the toolkit for gradually increasing exercise intensity and incorporating different types of exercises into their daily life.
The effects of the Stronger at Home program will be compared to those of usual care.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Stronger at Home Study
NCT04228068
Improving Functional Recovery After Hip Fracture
NCT00000436
The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care
NCT04947722
Frailty Intervention in Postoperative Hip Fracture Inpatients
NCT07027241
Effect of Leg Strengthening Exercise After Hip Fracture
NCT00997776
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In addition to the main research question, secondary aims of the project include evaluating the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge. The program's impact on functional recovery will also be assessed at medium-term (6 months) and long-term (12 months) follow-ups after the participants are discharged from the hospital to their homes.
The need for conducting this trial arises from a knowledge gap in effective rehabilitation programs for community-dwelling individuals with hip fractures. The Stronger at Home program was developed through a multistage study incorporating a self-directed toolkit and a new model of care. The development process involved critical analysis of previous programs, adherence to four principles of a successful program, and consultations with researchers, policymakers, older adults, and clinicians. The toolkit includes an educational component and an illustrated exercise program with progressively increasing intensity.
The pilot study of the Stronger at Home program has shown feasibility, with positive feedback from healthcare providers and patients regarding its value.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
In terms of its design, this trial is considered to be rather pragmatic to very pragmatic, as indicated by a score of 37 out of 45 on the PRECISE-2 tool. The PRECISE-2 tool is used to assess the level of pragmatism in clinical trials, helping to identify trials that closely resemble real-world conditions and are applicable to everyday practice.
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention (Stronger at Home model)
This study implements a 14-week home-based rehabilitation program for older adults after hip fractures. Participants will receive 8 home visits by a Physiotherapist (PT) and/or Physio assistant(PTA), focusing on individualized exercise programs and pain self-management. The intervention aims to improve functional recovery and includes PT-led assessments, exercise adjustments, and discharge assessments. PTAs support exercise delivery and education. The clinical team comprises PTs and PTAs, receiving training on exercise principles, pain education, and goal setting. The program emphasizes progressive strengthening, balance, and functional exercises, adhering to evidence-based principles. The intervention aims to enhance efficiency, reduce wait times, and promote adherence.
The Intervention (Stronger at Home Intervention)
The home-based intervention includes 8 visits by a PT and/or PTA. The PT conducts 3 visits for initial assessment, program design, coaching, and discharge assessments. The program targets personal goals and provides pain self-management support. The second PT visit at 6 weeks allows for reassessment and adjustments. The intervention ensures adherence through multiple sessions, tailored exercises, barrier-solving support, and motivational strategies. The PTA conducts solo visits every other week, assisting with exercises and education under PT supervision. This inclusion reduces wait times and improves efficiency. The clinical team consists of at least 2 PTs and 2 PTAs trained for 3 days. The exercise program adheres to evidence-based principles, involving a 30-minute session with warm-up, exercise, and cool-down. Participants are encouraged to exercise 5 times a week, focusing on strengthening, balance, and functionality. Feasible compliance rates were observed in the pilot study.
Control (usual care)
The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.
Usual care (Control)
The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Intervention (Stronger at Home Intervention)
The home-based intervention includes 8 visits by a PT and/or PTA. The PT conducts 3 visits for initial assessment, program design, coaching, and discharge assessments. The program targets personal goals and provides pain self-management support. The second PT visit at 6 weeks allows for reassessment and adjustments. The intervention ensures adherence through multiple sessions, tailored exercises, barrier-solving support, and motivational strategies. The PTA conducts solo visits every other week, assisting with exercises and education under PT supervision. This inclusion reduces wait times and improves efficiency. The clinical team consists of at least 2 PTs and 2 PTAs trained for 3 days. The exercise program adheres to evidence-based principles, involving a 30-minute session with warm-up, exercise, and cool-down. Participants are encouraged to exercise 5 times a week, focusing on strengthening, balance, and functionality. Feasible compliance rates were observed in the pilot study.
Usual care (Control)
The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Currently living in the community, and
* Either being discharged to their home or a retirement home
* Fall from a standing height or less
* Live within 45km radius of recruitment site
Exclusion Criteria
* Not a hip fracture (e.g., pelvic fracture)
* Unable to give consent and no proxy
* Fracture due to pathological disease (e.g., cancer, Paget's disease).
* Does not speak English and no translator
* Fracture sustained at hospital
* Terminal illness or exercise contraindications
* Discharged with other services not eligible
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Mohammad Auais, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Mohammad Auais, PhD
Associate Professor, School Of Rehabilitation Therapy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen's University
Kingston, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6032153
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.