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Completed

NCT Number: NCT04304495

The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department II

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fall Prevention

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in gait speed

    Time frame: 12 months

    Apple watch determined; average change in gait speed over 12-month follow-up

  2. 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)

  3. Number of recurrent falls

    Time frame: 12 months

    Number of falls in person months

  4. Number of ED re-visits

    Time frame: 12 months

    Any visit to the ED in the 12-month follow-up

  5. Rate of hospitalization

    Time frame: 12 months

    Any hospital admission in the 12-month follow-up

  6. Rate of permanent moves to nursing homes

    Time frame: 12 months

    Any move to a nursing home for >30 days

  7. Mortality rate

    Time frame: 12 months

    All cause patient mortality in follow-up

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Apple Inc.
  • National Institute on Aging (NIA)

Registry information

Official study title

GAPcare II: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department

Acronym: GAPcareII

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2020
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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