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 at 2 sites in United States.
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
- 2 sitesUnited States
- Study dates
- 13 Oct 2026to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCH University of Colorado
Aurora, Colorado, 80045
Trish Smith, MS, RD, 303-724-6295, GoldbergLab@cuanschutz.edu
Elizabeth Goldberg, MD, ScM
- Recruiting
Washington University
St Louis, Missouri, 63110
Jamie Mills, CCRC, MS, 314-747-4510, jamiem@wustl.edu
Stacey House, MD, PhD
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 start13 Oct 2026
- 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
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAPcareAD: A Brief Emergency Department Intervention to Address Post-Fall Care Needs of Persons Living With Dementia and Care Partners
- ClinicalTrials.gov ID
- NCT07563270
- Acronym / sponsor ID
- GAPcareAD / 24-1704
- Conditions
- Alzheimer's Disease and Related Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following consent, the patient participant will undergo random (1:1) allocation to the GAPcareAD intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fall PreventionGAPcareAD - See intervention description. |
| Usual Care | No intervention | –The ED clinician will perform a standard medical evaluation and care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall PreventionGAPcareAD - 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. | Other | Intervention |
Primary outcome
Effect of intervention
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall Prevention in people with Alzheimer's Disease and Related Dementia, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.