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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer's Disease and Related Dementia
• Intervention / Treatment: Other: Fall Prevention

Detailed Description

This multi-site randomized controlled trial will evaluate the efficacy of GAPcareAD compared to usual care among 350 PLWD and their caregivers (dyads) presenting to one of the three EDs after a fall. The intervention includes pharmacist- and physical therapist-led assessments, targeted modification of fall risk factors, and coordinated communication of fall prevention plans with caregivers and care teams. Outcomes include fall-related ED visits, injuries, hospitalizations, quality of life, caregiver burden, and adherence to recommendations over 6 months. GAPcareAD aims to determine whether a pragmatic, ED-based intervention can reduce fall-related healthcare utilization and improve patient and caregiver outcomes, while informing future large-scale implementation.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; GAPcareAD - See intervention description.	Other: Fall Prevention; 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.
No Intervention: Usual Care; The ED clinician will perform a standard medical evaluation and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 24-1704; NIH Grant: R01AG091334 (Other Identifier: National Institute on Aging (NIA))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No