Fall Prevention Program for Older Adults

(GAPcareII Trial)

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

197 Participants Needed

Trial Summary

What is the purpose of this trial?

In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Participants will be randomly assigned to usual care with a traditional fall evaluation by an ED clinician (i.e., ED medical staff member) or an intervention. In the intervention, participants will receive an in-ED consultation by a physical therapist and pharmacist to determine reasons for the fall and offer additional education and training. Participants will be provided an Apple Watch to record measures of fitness and falls, if possible, in the following 12 months. Recurrent falls will be measured in twelve-month follow-up.

Research Team

Elizabeth M Goldberg, MD, ScM

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+