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Recruiting NCT05972005

Stronger At Home: Improving Outcomes for Older Adults After Hip Fracture

No phase Interventional Hip Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Intervention (Stronger at Home Intervention), Usual care (Control).
Who it may be relevant to
Registry conditions: Hip Fractures. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Stronger At Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture

Overview

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.

Interventions

  • Other 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,
  • Other 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.

Primary outcome measures

  • The Lower Extremity Functional Scale (LEFS) [Time frame: 3.5 months (post intervention )]
Secondary outcome measures (8)
  • The Short Physical Performance Battery (SPPB) [Time frame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.]
  • Modified Falls Efficacy Scale [Time frame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.]
  • Pain measured with Numerical Analogue Scale (NAS) [Time frame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.]
  • Tampa Scale of Kinesiophobia (TSK) [Time frame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.]
  • 2-Minute Walk Test (2MWT) [Time frame: Baseline, and at 3.5 months, 6 months, and 12 months after discharge.]
  • Clinical Frailty Scale [Time frame: Baseline and 3.5 months, 6 months, 12 months after discharge]
  • Short Depression Scale [Time frame: Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge]
  • Short Fear of Falling Scale [Time frame: Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Queen's University — Kingston

Identifiers

NCT: NCT05972005 · 6032153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗