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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

Legally authorized representative able to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four) either over the phone with witness present or in person

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

GAPcareII Trial 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.Check my eligibility

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.See study design

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.

GAPcareII Trial Eligibility Criteria

Inclusion Criteria

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

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

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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.

GAPcareII Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of study activity completion

Secondary outcome measures

Change in activity level

Change in gait speed

Mortality rate

+4 more

GAPcareII 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 / 5Eligibility criteria met

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Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

71,537 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,351 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,004,867 Total Patients Enrolled

Media Library

Fall Prevention Clinical Trial Eligibility Overview. Trial Name: NCT04304495 — Phase 2

Falling. Research Study Groups: Intervention, Usual care arm

Falling. Clinical Trial 2023: Fall Prevention Highlights & Side Effects. Trial Name: NCT04304495 — Phase 2

Fall Prevention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04304495 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any new openings for this clinical research?

"According to publicly available information, this clinical trial is currently closed for recruitment. The original posting was on August 2nd 2021 with the last update being September 15th 2021. Although no longer admitting patients, there are 228 other trials actively in search of volunteers at present."

Answered by AI

What are the expected results of this experiment?

"The Apple Inc. sponsored study aims to track the Rate of study activity completion over a 12 month period, as well as secondary outcomes such as Number of Emergency Department re-visits, Activity level (as determined by an Apple watch), and ED revisits."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

The Geriatric Acute and Post-acute Fall Prevention Intervention (gapcare) II to Assess the Use of the Apple Watch in Older Emergency Department Patients with Falls: Protocol for a Mixed Methods Study

Strauss, Daniel H, Natalie M Davoodi, Margaret Healy, Christopher L Metts, Roland C Merchant, Swechya Banskota, and Elizabeth M Goldberg. 2021. “The Geriatric Acute and Post-acute Fall Prevention Intervention (gapcare) II to Assess the Use of the Apple Watch in Older Emergency Department Patients with Falls: Protocol for a Mixed Methods Study”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/24455.

clinicaltrials.govStudy

The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II

2021. "The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04304495.

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