Fall
Conditions
Keywords
prevention, emergency department, digital health, Apple Watch, physical therapy, pharmacy, GAPcare, Geriatric
Brief 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. 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.
Interventions
OTHERFall Prevention
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.
Sponsors
National Institute on Aging (NIA)
Apple Inc.
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be randomly assigned (by the REDCap program) 1:1 to the intervention or usual care arm.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of study activity completion | 12 months | Rate of participants who completed all study activities, including initial enrollment and multiple follow up visits over a 12 month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in activity level | 12 months | Apple watch determined; average change in proportion of time spent active per day (e.g. walking, running, not driving or sedentary) |
| Number of recurrent falls | 12 months | Number of falls in person months |
| Number of ED re-visits | 12 months | Any visit to the ED in the 12-month follow-up |
| Change in gait speed | 12 months | Apple watch determined; average change in gait speed over 12-month follow-up |
| Rate of permanent moves to nursing homes | 12 months | Any move to a nursing home for \>30 days |
| Mortality rate | 12 months | All cause patient mortality in follow-up |
| Rate of hospitalization | 12 months | Any hospital admission in the 12-month follow-up |
Countries
United States
Outcome results
None listed