- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07824141
Fall Prevention Pathways
Feasibility, Acceptability and Adherence of the Fall Prevention Pathways With Remote Monitoring
Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges.
This study builds on prior research demonstrating the feasibility of digital health interventions in rehabilitation and extends it to a structured, remotely monitored Fall Prevention Pathway (FPP). Preliminary work in digital rehabilitation has shown positive engagement and clinical outcomes, supporting the need for further exploration of feasibility, adherence, and cost implications of remotely monitored fall prevention programs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate the Fall Prevention Pathways (FPP) program, a digital rehabilitation intervention that assesses the impact of remote monitoring in reducing fall risk in community-dwelling older adults.
Participants will be enrolled in an 8-week intervention and followed for an additional 6 months. The study will assess feasibility, patient adherence, engagement, clinical outcomes, and cost implications. Data collection will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-ups at 13 weeks (3 months) and 26 weeks (6 months).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Madeleine E. Hackney, Ph.D.
- Phone Number: 314-412-4852
- Email: mehackn@emory.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Recruiting
- Executive Park
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Contact:
- Madeleine E. Hackney, PhD
- Phone Number: 314-412-4852
- Email: mehackn@emory.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 65-85 years
- Community-dwelling individuals classified as low to moderate fall risk based on standardized assessments, (i.e., the Stay Independent Screener)
- Ability to ambulate independently or with a single-point cane
- Willingness to participate in an 8-week intervention with remote monitoring
- Access to a smartphone, tablet, or computer with internet connectivity
- Ability to provide informed consent
Exclusion Criteria:
- Severe cognitive impairment or a diagnosis of dementia that would affect adherence or ability to provide consent
- Neurological or vestibular disorders (e.g., Parkinson's disease, multiple sclerosis, history of stroke with residual balance impairment)
- Severe comorbidities that significantly impact mobility and function (e.g., recent orthopedic surgery, unstable cardiac conditions)
- Significant visual or hearing impairments that prevent engagement with digital health interventions
- Non-ambulatory or requiring assistance of another person for mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The Fall Prevention Pathway (FPP)
Participants will be enrolled in an 8-week FPP intervention program.
After completion of the 8-week FPP intervention, participants will undergo long-term follow-up assessments at 13 weeks (3 months) and 26 weeks (6 months) post-intervention.
The follow-up assessments aim to assess sustained engagement, adherence, clinical outcomes, and fall incidence.
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The Fall Prevention Pathway (FPP) is a digital progression of exercises & patient education delivered through a web platform designed to improve balance, boost confidence, and reduce fall risk.
The FPP enrolls participants in a Medbridge Pathway and provides remote monitoring by a clinician who personalizes programs and provides verbal education to help reduce fall risk.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adherence to program
Time Frame: At the end of the intervention (8 weeks)
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Adherence will be measured as the number of participants who complete ≥3 days of activity per week
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At the end of the intervention (8 weeks)
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Number of participants who complete the intervention
Time Frame: 3 months and 6 months post-intervention
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Number of participants (Retention rate) who remain in the study
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3 months and 6 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30-Second Sit-to-Stand test
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance.
A higher score is better.
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Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Gait speed over 20 feet
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk within a 20-foot distance forward and Backwards using GAITRite.
GAITRite is a pressure-sensitive walkway that can assess gait anomalies.
Lower scores are better.
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Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Measures the time it takes to rise from a chair, walk 3 meters, turn around, and return to the chair in the simple condition.
In the Cognitive condition, one is required to simultaneously count backward by 3s from a number between 20 and 100; in the Manual condition, one is required to simultaneously pick up a cup of water and carry it while completing the task.
A lower score is a better outcome.
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Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Tandem stance (from 4 stage balance test),
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The tandem stance in the 4-Stage Balance Test is a static balance position where the participant stands with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. It assesses static balance and postural stability by significantly narrowing your base of support. Screens for fall risk, specifically in older adults. Scoring: Time tracked: Measured using a stopwatch up to 10 seconds with eyes open. Pass criteria: Must maintain the heel-to-toe position for 10 full seconds without moving the feet or grabbing support/the tester. Stop condition: The test stops immediately if the person cannot reach the 10-second mark, meaning their final score is recorded at the highest stage successfully completed. |
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Short Form 12-Quality of Life (SF12)
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The SF12 evaluates the level of activity and perceived physical and mental quality of life. The SF-12 uses a standardized system with scores ranging from 0 to 100, where the general population's average is 50, with higher scores indicating better health. Because it measures relative deviation, the numbers represent the following health levels: Above 50: Better than average health. Exactly 50: Average health status. 40 to 50: Below average health (mild disability or impairment). 30 to 40: Moderate disability or impairment. Below 40: Severe impairment or disability. |
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Falls Efficacy Scale (FES-I)
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The Falls Efficacy Scale-International (FES-I) measures a person's level of concern or fear about falling while performing 16 everyday indoor and outdoor activities. Each activity is rated on a 4-point Likert scale from 1 to 4; with 1 = Not at all concerned; 2 = Somewhat concerned; 3 = Fairly concerned and 4 = Very concerned. All 16 item scores are added together for the final sum. Minimum Score: 16 (indicates no concern about falling) Maximum Score: 64 (indicates severe or extreme concern about falling) |
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Activities-specific Balance Confidence Scale (ABC)
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire used to measure an individual's confidence in performing daily activities without losing their balance or feeling unsteady. Participants rate their self-confidence on a percentage scale from 0% (no confidence) to 100% (completely confident) for 16 specific tasks. The total score is added for all 16 items and divided by 16 to get the average percentage score. ≥ 80%: Indicates a high level of physical functioning and balance confidence. 50% to 80%: Indicates a moderate level of physical functioning. < 50%: Indicates a low level of physical functioning. Higher scores indicate a higher level of functioning and a lower risk of falling, while lower scores (below 67%) often indicate a higher risk of falling. Score Interpretation: 16-19: Low concern about falling 20-27: Moderate concern about falling 28-64: High concern about falling |
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Physical Activity Scale for the Elderly (PASE)
Time Frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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The PASE score combines information on leisure, household, and occupational activity.
The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others.
It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
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Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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Net Promoter Score (NPS)
Time Frame: 8 weeks (end of the intervention)
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The Net Promoter Score (NPS) will be used to measure the participants' satisfaction. A Net Promoter Score (NPS) is a customer loyalty and satisfaction metric that measures how likely a person is to recommend a company, product, or service to a friend or colleague. Businesses ask one simple survey question: "On a scale of 0 to 10, how likely are you to recommend us?" Promoters (Score 9-10): Loyal and enthusiastic fans who will keep buying and tell others. Passives (Score 7-8): Satisfied customers who are unenthusiastic and vulnerable to competitors. Detractors (Score 0-6): Unhappy customers who can damage your brand through negative word-of-mouth |
8 weeks (end of the intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Madeleine E. Hackney, Ph.D., Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025P011033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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