Recruiting

GAPcareAD

Sponsor:

University of Colorado, Denver

Code:

NCT07563270

Conditions

Alzheimer's Disease and Related Dementia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Fall Prevention

Study Details

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

Study ID

NCT07563270

Start date

Oct 13, 2026

Status verified date

May, 2026

Completion date

Mar 31, 2031

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

GAPcareAD - See intervention description.

no intervention: Usual Care

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

Interventions

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.

Primary outcome measure

  • Effect of intervention [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

UCH University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Trish Smith, MS, RD

303-724-6295GoldbergLab@cuanschutz.edu

Principal Investigator:

Elizabeth Goldberg, MD, ScM

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jamie Mills, CCRC, MS

314-747-4510jamiem@wustl.edu

Principal Investigator:

Stacey House, MD, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 9, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.