Old Age; DebilityNCT07824141
Fall Prevention Pathways
A study testing The Fall Prevention Pathway (FPP) in people with Old Age; Debility, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility
- What is being tested?
- The Fall Prevention Pathway (FPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Executive Park
Atlanta, Georgia, 30329
Madeleine E. Hackney, PhD, 314-412-4852, mehackn@emory.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Old Age; Debility
- Being tested
- The Fall Prevention Pathway (FPP)
- Keywords
- Older adults, Fall risk, Digital Program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Fall Prevention Pathway (FPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Fall Prevention Pathway (FPP) | Experimental | 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. Receives: Behavioral: The Fall Prevention Pathway (FPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to program
Adherence will be measured as the number of participants who complete ≥3 days of activity per week
Measured: At the end of the intervention (8 weeks)
Number of participants who complete the intervention
Number of participants (Retention rate) who remain in the study
Measured: 3 months and 6 months post-intervention
Secondary outcomes (9)
30-Second Sit-to-Stand test
The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Gait speed over 20 feet
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.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)
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.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Tandem stance (from 4 stage balance test),
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.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Short Form 12-Quality of Life (SF12)
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.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Falls Efficacy Scale (FES-I)
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)
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Activities-specific Balance Confidence Scale (ABC)
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
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Physical Activity Scale for the Elderly (PASE)
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.
Measured: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Net Promoter Score (NPS)
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
Measured: 8 weeks (end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start29 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Community-dwelling adults aged 65-85 years with low to moderate fall risk.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- medbridge
- Responsible party
- Principal investigator, Madeleine Eve Hackney, Emory University
- Investigators
- Madeleine E. Hackney, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824141
- Sponsor's protocol ID
- 2025P011033
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Adherence of the Fall Prevention Pathways With Remote Monitoring
- ClinicalTrials.gov ID
- NCT07824141
- Acronym / sponsor ID
- 2025P011033
- Conditions
- Old Age; Debility
- Keywords
- Older adults, Fall risk, Digital Program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- medbridge
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Community-dwelling adults aged 65-85 years with low to moderate fall risk.
| Arm | Type | Receives |
|---|---|---|
| The Fall Prevention Pathway (FPP) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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. | Behavioural | The Fall Prevention Pathway (FPP) |
Primary outcome
Adherence to program
Time frame: 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
Time frame: 3 months and 6 months post-intervention
Number of participants (Retention rate) who remain in the study
9 secondary outcomes
30-Second Sit-to-Stand test
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Gait speed over 20 feet
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
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)
Tandem stance (from 4 stage balance test),
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Short Form 12-Quality of Life (SF12)
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Falls Efficacy Scale (FES-I)
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Activities-specific Balance Confidence Scale (ABC)
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Physical Activity Scale for the Elderly (PASE)
Time frame: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Net Promoter Score (NPS)
Time frame: 8 weeks (end of the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeleine E. Hackney, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Fall Prevention Pathway (FPP) in people with Old Age; Debility, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine E. Hackney, Ph.D. (314-412-4852, mehackn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to program (time frame: At the end of the intervention (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.