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Stronger at Home: Improving Outcomes for Older Adults After Hip Fracture (S@H)

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Intervention (Stronger at Home Intervention)
Usual care (Control)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fracture, Exercise program, Recovery, Physical therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hip fracture patients who are 65 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 25km 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

Sites / Locations

  • Queen's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention (Stronger at Home model)

Control (usual care)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
2-Minute Walk Test (2MWT)
The 2MWT will be conducted to evaluate participants' mobility endurance. It measures the distance covered by participants during a 2-minute walk, providing information about their aerobic capacity and endurance.
Clinical Frailty Scale
A summary of the overall level of fitness and/or frailty. Scale of 1-9, with higher scores indicating higher degree of frailty.
Short Depression Scale
A 10-item questionnaire related to feelings of depression in the last week.
Short Fear of Falling Scale
Scale used to assess fear of falling, with higher scores indicating greater fear of falling

Full Information

First Posted
July 13, 2023
Last Updated
October 17, 2023
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT05972005
Brief Title
Stronger at Home: Improving Outcomes for Older Adults After Hip Fracture
Acronym
S@H
Official Title
Stronger at Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2023 (Actual)
Primary Completion Date
October 17, 2027 (Anticipated)
Study Completion Date
July 29, 2028 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip Fracture, Exercise program, Recovery, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
In this type of trial, the researchers responsible for assessing the outcomes remain unaware of the treatment assignments. The purpose of single-blind masking is to minimize bias and ensure that the assessment of outcomes is not influenced by researchers' expectations or knowledge of the treatment.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Stronger at Home model)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (usual care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The Intervention (Stronger at Home Intervention)
Other Intervention Name(s)
The Stronger at Home Physical Therapy program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care (Control)
Intervention Description
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 Measure Information:
Title
The Lower Extremity Functional Scale (LEFS)
Description
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 Outcome Measure Information:
Title
The Short Physical Performance Battery (SPPB)
Description
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.
Title
Modified Falls Efficacy Scale
Description
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.
Title
Pain measured with Numerical Analogue Scale (NAS)
Description
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.
Title
Tampa Scale of Kinesiophobia (TSK)
Description
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.
Title
2-Minute Walk Test (2MWT)
Description
The 2MWT will be conducted to evaluate participants' mobility endurance. It measures the distance covered by participants during a 2-minute walk, providing information about their aerobic capacity and endurance.
Time Frame
Baseline, and at 3.5 months, 6 months, and 12 months after discharge.
Title
Clinical Frailty Scale
Description
A summary of the overall level of fitness and/or frailty. Scale of 1-9, with higher scores indicating higher degree of frailty.
Time Frame
Baseline and 3.5 months, 6 months, 12 months after discharge
Title
Short Depression Scale
Description
A 10-item questionnaire related to feelings of depression in the last week.
Time Frame
Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge
Title
Short Fear of Falling Scale
Description
Scale used to assess fear of falling, with higher scores indicating greater fear of falling
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 Pre-specified Outcome Measures:
Title
Health-Related Quality of Life (HRQL)
Description
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.
Title
Quality-Adjusted Life Years (QALYs)
Description
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.
Title
Charlson Comorbidity Index
Description
Index developed to capture comorbidities and will be used at baseline to describe the population. Higher scores indicate greater comorbidity.
Time Frame
Baseline
Title
Sociodemographic information
Description
Survey questionnaire related to living status, employment, smoking status, alcohol consumption, height and weight, income, falls history.
Time Frame
Baseline
Title
Health Resource Utilization Questionnaire (adapted version)
Description
Questionnaire used to capture health utilization. Collects information related to the following: health professional visits, hospital stays, tests/investigations, medications taken, equipment used, access to community resources, time off work, need for paid assistance.
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.
Title
Health Resource Utilization diary
Description
Short questionnaire to facilitate data collection for the Health Resource Utilization Questionnaire. Monthly diary sent to participants to record medical appointments, hospital visits, tests, and medications.
Time Frame
Baseline; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months after enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hip fracture patients who are 65 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 25km 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Auais
Phone
(613) 533-2000
Ext
33112
Email
mohammad.auais@queensu.ca
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Auais
Phone
(613) 533-2000
Ext
33112
Email
mohammad.auais@queensu.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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