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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07563270
Acronym
GAPcareAD
Enrollment
700
Registered
2026-05-04
Start date
2026-09-30
Completion date
2031-03-31
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease and Related Dementia

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.

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.

Interventions

OTHERFall 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Effect of intervention6 monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026