Clinical trial NCT05972005: Stronger At Home: Improving Outcomes for Older Adults After Hip Fracture
Official title: Stronger At Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Keywords: Hip Fracture
Exercise program
Recovery
Physical therapy
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial (RCT) will be conducted over a period of 14 weeks, utilizing a parallel-group design. It will be a single-blind trial, meaning that the assessors will not be aware of participants assigned intervention. The trial will include repeated measures, with follow-ups conducted up to 12 months after the participants are discharged from the hospital.

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.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of a new 14-week individually-tailored home-based rehabilitation program called "Stronger at Home" with usual care in improving functional recovery in community-dwelling older adults after hip fractures.

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.

Detailed description: The primary research question of this project is whether the Stronger at Home program, a 14-week individually-tailored home-based rehabilitation program, is more effective than usual care in improving functional recovery in community-dwelling older adults after hip fractures. The evaluation of effectiveness will be conducted at the end of the intervention, which is the primary time point.

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.

Eligibility criteria: Inclusion Criteria:

* Hip fracture patients who are 55 years or older,
* 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:

* Came from long term care or discharged to long term care
* 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

Primary outcomes:
measure: The Lower Extremity Functional Scale (LEFS)
timeFrame: 3.5 months (post intervention )
Secondary outcomes:
measure: The Short Physical Performance Battery (SPPB)
timeFrame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
measure: Modified Falls Efficacy Scale
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
measure: Pain measured with Numerical Analogue Scale (NAS)
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
measure: 2-Minute Walk Test (2MWT)
timeFrame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
measure: Clinical Frailty Scale
timeFrame: Baseline and 3.5 months, 6 months, 12 months after discharge
measure: Short Depression Scale
timeFrame: Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge
measure: Short Fear of Falling Scale
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
Other outcomes:
measure: Health-Related Quality of Life (HRQL)
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: within 7 days of discharge, as well as within 3.5 months, 6 months, 9 months, and 12 months.
measure: Charlson Comorbidity Index
timeFrame: Baseline
measure: Sociodemographic information
timeFrame: Baseline
measure: Health Resource Utilization Questionnaire (adapted version)
timeFrame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.
measure: Health Resource Utilization diary
timeFrame: Baseline; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months after enrollment.
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References: