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

Fall Clinical Trial

— GAPcareII  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04304495
• Other study ID #: 22-2089
• Secondary ID: K76AG059983
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 6, 2021
• Est. completion date: August 2, 2025

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In order to determine whether a multifactorial fall prevention intervention is feasible, acceptable and may reduce recurrent falls in older adults presenting to the ED after a fall, we will randomize patients to usual care with a traditional fall evaluation by an ED clinician or an intervention. Patients in the intervention arm receive a fall risk assessment and recommendations by a physical therapist. They are also evaluated by a pharmacist and participate in a medication therapy management session with the aim to reduce fall risk increasing medication.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 197
• Est. completion date: August 2, 2025
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall

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

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

• Will be discharged to home/assisted living/rehabilitation at completion of ED visit (i.e., not admitted)

• 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

• Must screen or test negative for COVID-19

Exclusion Criteria:

• Unable to give informed consent due to intoxication or altered mental status

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

• Allergies to any wearable device component

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

• Patient has advanced cancer and/or is on hospice care

• Pts coming from SNF or nursing home

• Previously enrolled in GAPcare II Aim1.b

Related Conditions & MeSH terms

• Emergencies
• Fall

Intervention

Other:
• Fall Prevention
The intervention arm participants will receive a physical therapy and pharmacy consults as well as Apple Watch training and an Apple Watch device to test memory and mobility during the ED visit and during our home visits.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Rhode Island Hospital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Apple Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Strauss DH, Davoodi NM, Healy M, Metts CL, Merchant RC, Banskota S, Goldberg EM. 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 Res Protoc. 2021 Apr 1;10(4):e24455. doi: 10.2196/24455. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of study activity completion	Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period	12 months
Secondary	Change in gait speed	Apple watch determined; average change in gait speed over 12-month follow-up	12 months
Secondary	Change in activity level	Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary)	12 months
Secondary	Number of recurrent falls	Number of falls in person months	12 months
Secondary	Number of ED re-visits	Any visit to the ED in the 12-month follow-up	12 months
Secondary	Rate of hospitalization	Any hospital admission in the 12-month follow-up	12 months
Secondary	Rate of permanent moves to nursing homes	Any move to a nursing home for >30 days	12 months
Secondary	Mortality rate	All cause patient mortality in follow-up	12 months