Fall Prevention Program for Older Adults

(GAPcareII Trial)

No longer recruiting at 2 trial locations

Overseen By Megan Bounds, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Intoxication, Advanced cancer, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: Initial ED visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the risk of falls for older adults by comparing two approaches. One group will receive usual care, while the other will have an additional consultation with a physical therapist and pharmacist to assess fall risks and medications. Participants will also use an Apple Watch to track their fitness and any falls over a year. This Fall Prevention Program suits individuals aged 65 or older who have recently fallen and are returning home after an emergency department visit. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve fall prevention strategies for older adults.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this fall prevention program is safe for older adults?

Research has shown that fall prevention programs are generally safe for older adults. Many studies have found that these programs significantly reduce the number of falls and are well-received by participants. For example, a program tailored to individual needs led to fewer falls and less fear of falling among those who participated.

These programs typically include assessments and personalized advice. In one trial, participants received consultations from physical therapists and pharmacists. These sessions identified potential causes of falls and provided guidance on medication use. Because these interventions focus on education and safety rather than medical procedures, participants usually find them easy to handle.

Overall, fall prevention strategies have a strong record of being safe and helpful. Participants often feel more confident and secure after engaging in these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines physical therapy, pharmacy consultation, and innovative technology to prevent falls in older adults. Unlike standard care, which primarily focuses on immediate medical evaluation and treatment of injuries, this approach includes a fall risk assessment and medication review aimed at reducing fall risks. Additionally, the use of Apple Watches to monitor memory and mobility offers a modern, tech-driven way to track progress and potentially prevent future falls. This comprehensive, proactive strategy could lead to more effective fall prevention, enhancing the safety and quality of life for older adults.

What evidence suggests that this trial's Fall Prevention Program could be effective for preventing falls in older adults?

Studies have shown that fall prevention programs can reduce falls in older adults. Research highlights that programs with home visits or personalized plans are especially effective. For instance, one study found that a single home visit was both effective and affordable in preventing falls. Other studies have shown that most participants who completed fall prevention programs reported fewer falls afterward. In this trial, participants in the intervention arm will receive a fall prevention program that includes physical therapy and pharmacy consultations, combining medical advice with personalized plans. This approach, involving physical therapists and pharmacists, aims to greatly reduce the risk of falls. ^{2 6 7 8 9}

Who Is on the Research Team?

Elizabeth M Goldberg, MD, ScM

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for community-dwelling adults aged 65 or older who have fallen and visited the emergency department but will not be admitted to the hospital. They must test negative for COVID-19, and their fall should not be due to syncope, external force, or serious illness like stroke. Those with allergies to wearable devices or unable to wear an Apple Watch are excluded.

Inclusion Criteria

I have a legal representative to consent for me due to cognitive issues.

My recent fall was not caused by a stroke or heart attack.

My fall was not caused by fainting or an external force like being hit.

Exclusion Criteria

Unable or unwilling to wear Apple Watch at home (only for periodic study visits)

My cancer is advanced or I am receiving hospice care.

You are allergic to any material used in the wearable device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either usual care or an intervention with physical therapy and pharmacy consultation in the ED. They are also trained to use an Apple Watch for monitoring.

Initial ED visit

1 visit (in-person)

Follow-up

Participants are monitored for recurrent falls and other outcomes using an Apple Watch over a 12-month period with home visits at 1, 3, 6, and 12 months.

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fall Prevention

Trial Overview The study tests a multidisciplinary approach to prevent falls in older adults. Participants either receive usual care or an intervention involving a physical therapist and pharmacist consultation in the ED, plus education and training. They'll also use an Apple Watch for a year to track fitness and falls.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

In addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques. The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.

Group II: Usual care arm Active Control 1 Intervention

The ED clinician will perform a standard medical evaluation, including a focused history and exam to identify injuries, laboratory tests and radiologic imaging. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment.

Fall Prevention is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Fall Prevention for:

• Prevention of falls in older adults
• Reduction of fall-related injuries

Approved in Canada as Fall Prevention Program for:

• Prevention of falls in seniors
• Improvement of mobility and balance

Approved in European Union as FP for:

• Prevention of falls in elderly populations
• Reduction of fall-related hospitalizations

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Apple Inc.

Industry Sponsor

Trials

24

Recruited

1,792,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11864948/

a study on participant risk levels and program congruency - PMC As of June 2022, 16 fall prevention programs were approved by the ACL as meeting the evidence-based standard of effectiveness for community- ...

2. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05586-x

Effectiveness and cost-effectiveness of a single home-based ... This fall prevention programme with a single home visit was found to be effective and cost effective. Health policies should establish such a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10924894/

Evaluation of a Fall Prevention Program to Reduce ... Of the 43 older adults and 8 adults with disabilities who reported a fall, most reported having one fall (54.9%, n=28) since the completion of ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2819574

Interventions to Prevent Falls in Older Adults: Updated ... Objective To systematically review evidence on the effectiveness and harms of fall prevention interventions in community-dwelling older adults.

5. cdc.gov cdc.gov/falls/data-research/facts-stats/index.html

Facts About Falls | Older Adult Fall Prevention More than one out of four older people falls each year, but less than half tell their doctor. Falling once doubles your chances of falling again.

6. cdc.gov cdc.gov/falls/data-research/index.html

Older Adult Falls Data 1 Over 14 million, or 1 in 4 older adults report falling every year.2 This chart shows the number of older adult fall-related deaths by month ...

7. ncoa.org ncoa.org/article/the-national-reach-of-falls-prevention-programs-participant-demographics-and-program-outcomes/

Falls Prevention Programs: Who They Reach and How ... According to the Healthy Aging Programs Integrated Database (HAPID®), over 183,000 lives have been impacted by falls prevention programs held at ...

8. apha.org apha.org/policy-and-advocacy/public-health-policy-briefs/policy-database/2024/01/16/falls-prevention

Falls Prevention in Adults 65 Years and Over The CDC's STEADI algorithm provides a framework for providers to quickly screen community-dwelling adults 65 years and older for fall risk, ...

9. psnet.ahrq.gov psnet.ahrq.gov/perspective/ongoing-journey-prevent-patient-falls

The Ongoing Journey to Prevent Patient Falls | PSNet This piece explores the importance of preventing falls, risk factors, and the current research around fall prevention strategies.