Alzheimer's Disease and Related DementiaGAPcareADNCT07563270
GAPcareAD: A Brief Emergency Department Intervention to Address Post-Fall Care Needs of Persons Living With Dementia and Care Partners
A study testing Fall Prevention in people with Alzheimer's Disease and Related Dementia, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease and Related Dementia
- What is being tested?
- Fall Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Mar 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease and Related Dementia
- Being tested
- Fall Prevention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall PreventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | GAPcareAD - See intervention description. Receives: Other: Fall Prevention |
| Usual Care | No intervention | The ED clinician will perform a standard medical evaluation and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease and Related DementiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following consent, the patient participant will undergo random (1:1) allocation to the GAPcareAD intervention or control.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563270
- Sponsor's protocol ID
- 24-1704
- Other IDs
- NIH Grant: R01AG091334
- Acronym
- GAPcareAD
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No