GAPcareAD: A Brief Emergency Department Intervention to Address Post-Fall Care Needs of Persons Living With Dementia and Care Partners

NCT07563270 | Not Yet Recruiting DMC

• 2 other identifiers: 24-1704NIH Grant: R01AG091334
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persons living with dementia (PLWD) are at significantly increased risk for falls, which are the leading cause of emergency department (ED) visits in this population and contribute to serious injuries, functional decline, and caregiver burden. GAPcareAD is an ED-initiated, caregiver-inclusive intervention designed to address fall risk at the point of care. This multi-site trial will compare GAPcareAD (intervention) to usual care for 350 PLWD and caregivers after a fall.

Conditions

Alzheimer's Disease and Related Dementia

Outcome Measures

Primary Outcomes (1)

• Effect of intervention

  The primary outcome is the number of fall-related emergency department visits per participant within 6 months after randomization, comparing participants receiving the GAPcareAD intervention verses usual care.

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

GAPcareAD - See intervention description.

Other: Fall Prevention

Usual Care

NO INTERVENTION

The ED clinician will perform a standard medical evaluation and care.

Interventions

Fall Prevention OTHER

GAPcareAD - Pharmacists perform medication review and recommend modifying fall risk increasing medication. PTs perform fall risk assessments and tailor recommendations based on fall risk and patient's gait, balance, and mobility impairments. Through purposeful engagement by staff, caregivers are encouraged to contribute to the action plans.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling adult (living at home or assisted living) 65 years-old or older presenting to ED after a fall within the last seven days
• Fall not due to syncope or external force (i.e., struck by car,assault, intoxication)
• Fall not due to serious illness (i.e., stroke, acute myocardial infarction)
• Patients have an identified caregiver
• Patient must have known ADRD or score ≥2 on the AD8 Dementia Interview.
• Anticipated to be discharged to home/assisted living/rehabilitation at the time of consent (i.e. not admitted)
• The patient and/or caregiver have a reliable phone number where they can be reached throughout the intervention

You may not qualify if:

• Living in a nursing home
• Patients are admitted to the hospital
• Patients who have advanced cancer and/or are in hospice
• Patients have presence of injuries that prevent mobilization (i.e. pelvic or lower extremity fractures)

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Colorado, Denver: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Following consent, the patient participant will undergo random (1:1) allocation to the GAPcareAD intervention or control.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 31, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04