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

ConditionHip Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorDr. Mohammad Auais, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • The Intervention (Stronger at Home Intervention)

    Other 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)

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention (Stronger at Home model)Experimental treatment 1 intervention
Group B: Control (usual care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Lower Extremity Functional Scale (LEFS)

The primary outcome of the study (functional abilities) will be assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported outcome measure consisting of 20 items. The LEFS has been validated for various populations, including patients recovering from hip surgeries, and has shown excellent reliability, validity, and responsiveness. It provides a score ranging from 0 to 80 based on the responses to each item's options. The LEFS was chosen based on its ability to evaluate important functional activities for patients, and its use as a primary outcome in the pilot study helped determine the sample size for this trial.

Time frame
3.5 months (post intervention )

Secondary outcomes

1

The Short Physical Performance Battery (SPPB)

The Short Physical Performance Battery (SPPB) will be used as a secondary measure of physical function. The SPPB is a performance-based assessment that includes three tests: standing balance, gait speed, and chair-rising. The total score ranges from 0 to 12, with higher scores indicating better lower extremity physical performance. The SPPB has been extensively validated and used in geriatric research.

Time frame
Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
2

Modified Falls Efficacy Scale

The Modified Falls Efficacy Scale (MFES) is a commonly used self-report measure designed to assess an individual's confidence in their ability to perform daily activities without falling. It evaluates balance confidence and fear of falling in older adults or individuals with balance impairments. The scale consists of various activities or situations in which falls may occur, and respondents rate their level of confidence in performing each task without falling. The MFES typically consists of 14 or 16 items, and each item is rated on a scale ranging from 0% (no confidence) to 100% (complete confidence). The items cover a wide range of activities, including both basic and more complex tasks such as walking on various surfaces, climbing stairs, reaching overhead, and getting out of a chair.

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.
3

Pain measured with Numerical Analogue Scale (NAS)

The NAS will be utilized to assess pain intensity. Participants will be asked to rate their pain levels at rest and during walking on a scale ranging from 0 to 10, with higher scores indicating greater pain intensity.

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.
4

Tampa Scale of Kinesiophobia (TSK)

The TSK will be employed to measure pain-related fear. It assesses individuals' fear and avoidance of physical activity due to pain and provides insights into how fear influences their functional recovery.

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.

Other outcomes

1

Health-Related Quality of Life (HRQL)

HRQL refers to the impact of a health condition or intervention on a person's well-being. In this study, HRQL will be measured using the EQ-5D. EQ-5D is a generic instrument assessing HRQL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels (1 = no problems, 2 = some problems, 3 = severe problems).

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

Quality-Adjusted Life Years (QALYs)

QALYs are a measure of the quantity and quality of life lived. They combine information on HRQL and life expectancy to provide a single summary measure of health outcomes. QALYs will be calculated by assigning utility weights to the HRQL scores obtained from participants and multiplying them by the time spent in that health state.The measurement scale for QALYs ranges from 0 to 1, where 0 represents death and 1 represents perfect health. QALYs are calculated by multiplying the utility weight assigned to a specific health state (obtained from HRQL measures) by the time spent in that state.

Time frame
within 7 days of discharge, as well as within 3.5 months, 6 months, 9 months, and 12 months.
3

Charlson Comorbidity Index

Index developed to capture comorbidities and will be used at baseline to describe the population. Higher scores indicate greater comorbidity.

Time frame
Baseline
4

Sociodemographic information

Survey questionnaire related to living status, employment, smoking status, alcohol consumption, height and weight, income, falls history.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Mohammad Auais, PhD

Lead sponsor

Queen's University

Sponsor institution