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Fall Prevention Program for Older Adults (GAPcareII Trial)

Phase 2

Waitlist Available

Led By Elizabeth M Goldberg, MD, ScM

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fall not due to serious illness (i.e., stroke, acute myocardial infarction)

Fall not due to syncope or external force (i.e., struck by car or assault)

Must not have

Patient has advanced cancer and/or is on hospice care

Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new way to prevent falls in older adults that includes an evaluation by a physical therapist and pharmacist in addition to the usual care by an ED clinician. The study will last for 12 months and measure recurrent falls.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may not be direct side effects from the interventions as they involve assessments and monitoring rather than medications; however, participants might experience discomfort wearing the Apple Watch or stress related to adherence with new prevention strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 65 or older, live at home, and recently fell.

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I will go home or to a care facility after my emergency department visit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is advanced or I am receiving hospice care.

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I have injuries that stop me from moving around easily.

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I am able to understand and consent to my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of study activity completion

Secondary study objectives

Change in activity level

Change in gait speed

Mortality rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 armActive Control1 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.

0 / 7Eligibility criteria met