Old Age; Debility
Conditions
Keywords
Older adults, Fall risk, Digital Program
Brief summary
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.
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).
Interventions
BEHAVIORALThe Fall Prevention Pathway (FPP)
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.
Sponsors
Emory University
medbridge
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Community-dwelling adults aged 65-85 years with low to moderate fall risk.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to program | At the end of the intervention (8 weeks) | Adherence will be measured as the number of participants who complete ≥3 days of activity per week |
| Number of participants who complete the intervention | 3 months and 6 months post-intervention | Number of participants (Retention rate) who remain in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-Second Sit-to-Stand test | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better. |
| Gait speed over 20 feet | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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. |
| Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual) | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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. |
| Tandem stance (from 4 stage balance test), | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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. |
| Short Form 12-Quality of Life (SF12) | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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. |
| Falls Efficacy Scale (FES-I) | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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) |
| Activities-specific Balance Confidence Scale (ABC) | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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 |
| Physical Activity Scale for the Elderly (PASE) | Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention) | 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. |
| Net Promoter Score (NPS) | 8 weeks (end of the intervention) | 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 |
Countries
United States
Contacts
CONTACTMadeleine E. Hackney, Ph.D.
PRINCIPAL_INVESTIGATORMadeleine E. Hackney, Ph.D.
Emory University
Outcome results
None listed