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NCT04235374 · ClinicalTrials.gov registry record · NA

Implementation of Function Focused Care in Acute Care

A NA study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
455
Enrollment target

NCT04235374: Completed NA study, sponsored by University of Maryland, Baltimore.

NCT04235374 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 455 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04235374, a NA study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
455 participants
Enrollment target

Study Summary

Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 p

Primary Outcome

A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.

Interventions

  • BEHAVIORAL FFC-AC-EIT

Trial Details

FieldValue
Enrollment Target 455 participants
Start Date 2020-10-19
Est. Completion 2025-05-14
Phase NA
University of Maryland, Baltimore

560 total trials

What the finished NCT04235374 record still lists

NCT04235374 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 1 intervention - of which FFC-AC-EIT is the first listed.

NCT04235374 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04235374 about?

NCT04235374 is a clinical study titled "Implementation of Function Focused Care in Acute Care". Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activi...

What is the current status of trial NCT04235374?

This trial is currently completed. It is a NA study. The enrollment target is 455 participants. The study started on 2020-10-19. Estimated completion is 2025-05-14.

What interventions are being tested in trial NCT04235374?

The interventions under investigation include: FFC-AC-EIT (BEHAVIORAL).

Who is sponsoring clinical trial NCT04235374?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04235374's enrollment target sits among peer trials

455 224th of 2000 higher than 1,777 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04235374, the US trial registry maintained by the National Library of Medicine. NCT04235374 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.