NCT04235374Completed
Implementation of Function Focused Care in Acute Care
Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
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 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 455 (actual)
- First submitted
- 15 Jan 2020
- Start date
- 19 Oct 2020
- Primary completion date
- 14 May 2025
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Alzheimer disease
- NCT number
- NCT04235374
What you commit to
- Study type: Interventional
- Participants enrolled: 455
- From 19 Oct 2020 to the primary completion date, 14 May 2025
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- anticipate surgery; or
Other illness
- have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.
Other
- are enrolled in Hospice;
- have been on the unit for greater than 48 hours;
- do not have a family member/caregiver that we can contact;
Who the study is looking for
- are admitted into the hospital from any setting during the 12 month implementation period;
- are 55 years of age or older;
- are admitted onto a medical unit for any medical diagnosis; and
- screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of \>2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jefferson Abbington Coordinator of this site? Confirm its status | Abington | United States | Unknown status |
| Luminus Anne Arundel Medical Center Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| University of Maryland Baltimore Washington Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Midtown Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Maryland Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Maryland Baltimore Washington Medical Center Coordinator of this site? Confirm its status | Glen Burnie | United States | Unknown status |
| Lancaster Hospital Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Jefferson Lansdale Coordinator of this site? Confirm its status | Lansdale | United States | Unknown status |
| University of maryland Upper Chesapeake Hospital Coordinator of this site? Confirm its status | Perryville | United States | Unknown status |
| Jefferson Lansdale (control); Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Jefferson Methodist Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Hospital University of Pennsylvania - Cedar Avenue Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Maryland Saint Joseph Medical Center Coordinator of this site? Confirm its status | Towson | United States | Unknown status |
| Chester County Hospital Coordinator of this site? Confirm its status | West Chester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.