FallGAPcareIINCT04304495
The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II
A study testing Fall Prevention in people with Fall, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Fall Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2021to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
- Fall not due to syncope or external force (i.e., struck by car or assault)
- Fall not due to serious illness (i.e., stroke, acute myocardial infarction)
- Will be discharged to home/assisted living/rehabilitation at completion of ED visit (i.e., not admitted)
- Legally authorized representative able to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four) either over the phone with witness present or in person
- Must screen or test negative for COVID-19
Who cannot join
- Unable to give informed consent due to intoxication or altered mental status
- Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)
- Allergies to any wearable device component
- Unable or unwilling to wear Apple Watch at home (only for periodic study visits)
- Patient has advanced cancer and/or is on hospice care
- Pts coming from SNF or nursing home
- Previously enrolled in GAPcare II Aim1.b
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Participants will be randomly assigned to usual care with a traditional fall evaluation by an ED clinician (i.e., ED medical staff member) or an intervention. In the intervention, participants will receive an in-ED consultation by a physical therapist and pharmacist to determine reasons for the fall and offer additional education and training. Participants will be provided an Apple Watch to record measures of fitness and falls, if possible, in the following 12 months. Recurrent falls will be measured in twelve-month follow-up.
Read the detailed description
In order to determine whether a multifactorial fall prevention intervention is feasible, acceptable and may reduce recurrent falls in older adults presenting to the ED after a fall, we will randomize patients to usual care with a traditional fall evaluation by an ED clinician or an intervention. Patients in the intervention arm receive a fall risk assessment and recommendations by a physical therapist. They are also evaluated by a pharmacist and participate in a medication therapy management session with the aim to reduce fall risk increasing medication.
- Conditions
- Fall
- Being tested
- Fall Prevention
- Keywords
- prevention, emergency department, digital health, Apple Watch, physical therapy, pharmacy, GAPcare, Geriatric
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall PreventionOther
The intervention arm participants will receive a physical therapy and pharmacy consults as well as Apple Watch training and an Apple Watch device to test memory and mobility during the ED visit and during our home visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques.
The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment. Receives: Other: Fall Prevention |
| Usual care arm | No intervention | The ED clinician will perform a standard medical evaluation, including a focused history and exam to identify injuries, laboratory tests and radiologic imaging. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of study activity completion
Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period
Measured: 12 months
Secondary outcomes (7)
Change in gait speed
Apple watch determined; average change in gait speed over 12-month follow-up
Measured: 12 months
Change in activity level
Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary)
Measured: 12 months
Number of recurrent falls
Number of falls in person months
Measured: 12 months
Number of ED re-visits
Any visit to the ED in the 12-month follow-up
Measured: 12 months
Rate of hospitalization
Any hospital admission in the 12-month follow-up
Measured: 12 months
Rate of permanent moves to nursing homes
Any move to a nursing home for >30 days
Measured: 12 months
Mortality rate
All cause patient mortality in follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start6 Jan 2021
- Primary completion2 Feb 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Apple Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Goldberg, MD, ScM, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304495
- Sponsor's protocol ID
- 22-2089
- Other IDs
- K76AG059983
- Acronym
- GAPcareII
- Status last verified
- May 2025
- First submitted
- 6 Dec 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strauss DH, Davoodi NM, Healy M, Metts CL, Merchant RC, Banskota S, Goldberg EM. The Geriatric Acute and Post-Acute Fall Prevention Intervention (GAPcare) II to Assess the Use of the Apple Watch in Older Emergency Department Patients With Falls: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Apr 1;10(4):e24455. doi: 10.2196/24455.
PubMed 33792553Hartman CA, Leroux A, Merchant RC, Roberts S, Bettcher BM, Lum HD, Resnik L, Berry SD, Mealer M, Mor V, Goldberg E. Smartphone-Based Measurement of Cognition and Physical Function in Older Emergency Department Patients: A Feasibility Study. Acad Emerg Med. 2026 Sep;33(9):e70408. doi: 10.1111/acem.70408.
PubMed 42775945
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
- ClinicalTrials.gov ID
- NCT04304495
- Acronym / sponsor ID
- GAPcareII / 22-2089
- Conditions
- Fall
- Keywords
- prevention, emergency department, digital health, Apple Watch, physical therapy, pharmacy, GAPcare, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Apple Inc.
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 11 Mar 2020 (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.
In brief, this K76 study consists of a small open trial to refine the study protocol and train study personnel on study procedures (Aim 1.b.). In Aim 2, we will recruit older adults into a multidisciplinary fall prevention pilot study. Participants will be randomly assigned to usual care with a traditional fall evaluation by an ED clinician (i.e., ED medical staff member) or an intervention. In the intervention, participants will receive an in-ED consultation by a physical therapist and pharmacist to determine reasons for the fall and offer additional education and training. Participants will be provided an Apple Watch to record measures of fitness and falls, if possible, in the following 12 months. Recurrent falls will be measured in twelve-month follow-up.
Detailed description
In order to determine whether a multifactorial fall prevention intervention is feasible, acceptable and may reduce recurrent falls in older adults presenting to the ED after a fall, we will randomize patients to usual care with a traditional fall evaluation by an ED clinician or an intervention. Patients in the intervention arm receive a fall risk assessment and recommendations by a physical therapist. They are also evaluated by a pharmacist and participate in a medication therapy management session with the aim to reduce fall risk increasing medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Fall PreventionIn addition to the usual care arm, the Intervention arm will receive a physical therapy and pharmacy consultation in the ED. PTs will perform a fall risk assessment and provide recommendations on the safety of discharge. Pharmacists will perform medication review, recommend cessation or tapering of medication that increase fall risk using motivational interviewing (MTM) techniques. The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment. |
| Usual care arm | No intervention | –The ED clinician will perform a standard medical evaluation, including a focused history and exam to identify injuries, laboratory tests and radiologic imaging. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The participants will also receive Apple Watch training and an Apple Watch to perform tasks that test their memory and mobility during their ED visit and during our home visits at 1,3, 6, and 12 month after enrollment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
- Fall not due to syncope or external force (i.e., struck by car or assault)
- Fall not due to serious illness (i.e., stroke, acute myocardial infarction)
- Will be discharged to home/assisted living/rehabilitation at completion of ED visit (i.e., not admitted)
- Legally authorized representative able to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four) either over the phone with witness present or in person
Key exclusion criteria (7 listed)
- Unable to give informed consent due to intoxication or altered mental status
- Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)
- Allergies to any wearable device component
- Unable or unwilling to wear Apple Watch at home (only for periodic study visits)
- Patient has advanced cancer and/or is on hospice care
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 PreventionThe intervention arm participants will receive a physical therapy and pharmacy consults as well as Apple Watch training and an Apple Watch device to test memory and mobility during the ED visit and during our home visits. | Other | Intervention |
Primary outcome
Rate of study activity completion
Time frame: 12 months
Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period
7 secondary outcomes
Change in gait speed
Time frame: 12 months
Change in activity level
Time frame: 12 months
Number of recurrent falls
Time frame: 12 months
Number of ED re-visits
Time frame: 12 months
Rate of hospitalization
Time frame: 12 months
Rate of permanent moves to nursing homes
Time frame: 12 months
Mortality rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 33792553Strauss DH, Davoodi NM, Healy M, Metts CL, Merchant RC, Banskota S, Goldberg EM. The Geriatric Acute and Post-Acute Fall Prevention Intervention (GAPcare) II to Assess the Use of the Apple Watch in Older Emergency Department Patients With Falls: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Apr 1;10(4):e24455. doi: 10.2196/24455.
- Derived from this study: PubMed 42775945Hartman CA, Leroux A, Merchant RC, Roberts S, Bettcher BM, Lum HD, Resnik L, Berry SD, Mealer M, Mor V, Goldberg E. Smartphone-Based Measurement of Cognition and Physical Function in Older Emergency Department Patients: A Feasibility Study. Acad Emerg Med. 2026 Sep;33(9):e70408. doi: 10.1111/acem.70408.
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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. This study is not recruiting at the moment.
Elizabeth M Goldberg, MD, ScM principal investigator
University of Colorado, Denver
3 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 Fall, run by University of Colorado, Denver at 3 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of study activity completion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304495, which also lists 2 linked publications.
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 31 May 2025.