- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304495
The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II (GAPcareII)
GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Megan Bounds, MPH
- Phone Number: 303-724-4712
- Email: megan.bounds@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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. |
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.
|
No Intervention: Usual care arm
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait speed
Time Frame: 12 months
|
Apple watch determined; average change in gait speed over 12-month follow-up
|
12 months
|
Change in activity level
Time Frame: 12 months
|
Apple watch determined; average change in proportion of time spent active per day (e.g.
walking, running, not driving or sedentary)
|
12 months
|
Number of recurrent falls
Time Frame: 12 months
|
Number of falls in person months
|
12 months
|
Number of ED re-visits
Time Frame: 12 months
|
Any visit to the ED in the 12-month follow-up
|
12 months
|
Rate of hospitalization
Time Frame: 12 months
|
Any hospital admission in the 12-month follow-up
|
12 months
|
Rate of permanent moves to nursing homes
Time Frame: 12 months
|
Any move to a nursing home for >30 days
|
12 months
|
Mortality rate
Time Frame: 12 months
|
All cause patient mortality in follow-up
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth M Goldberg, MD, ScM, University of Colorado, Denver
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-2089
- K76AG059983 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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