FFC-AC-EIT for Dementia

University of maryland Upper Chesapeake Hospital, Perryville, MD
Dementia+2 More ConditionsFFC-AC-EIT - Behavioral
Eligibility
18+
All Sexes

Study Summary

This trial is testing the efficacy of a new approach to care for older adults with Alzheimer's Disease and Related Dementias (ADRD) that encourages physical activity during hospitalization. The new approach, called Function Focused Care for Acute Care (FFC-AC-EIT), is being tested against standard care (Function Focused Care Education Only, or EO) in 12 hospitals. The primary outcomes being measured are physical activity, function, and participation in function focused care.

Eligible Conditions
  • Dementia
  • Acute Medical Event
  • Hospitalizations

Treatment Effectiveness

Study Objectives

8 Primary · 4 Secondary · Reporting Duration: Number of ER visits in the 1st month post discharge; number of ER visits between the 1st month to 6th month post discharge; number of ER visits between 6th and 12th months post discharge

Day 3
Motionwatch8 data
Day 3
Patient Checklist for Function Focused Care
Number of ER visits in the 1st month post discharge; number of ER visits between the 1st month to 6th month post discharge; number of ER visits between 6th and 12th months post discharge
Emergency room (ER) visits
Number of NH admissions in the 1st month post discharge; number of NH admissions between the 1st month to 6th month post discharge; number of NH admissions between 6th and 12th months post discharge
nursing home (NH) admissions
Number of falls between admission to discharge; Number of falls in the first month post discharge; number of falls between the first month to sixth month post discharge; number of falls between 6 and 12th month
Falls
Number of hospitalizations in the 1st month post discharge; number of hospitalizations between the 1st month to 6th month post discharge; number of hospitalizations between 6th and 12th months post discharge
hospitalizations
Month 12
Barthel Index
Delirium Rating Scale
Pain in Advanced Dementia Scale (PAINAD)
The Confusion Assessment Method
The Physical Activity Survey
the Brief Neuropsychiatric Invesntory

Trial Safety

Trial Design

2 Treatment Groups

FFC-AC-EIT
1 of 2
Education Only
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: FFC-AC-EIT · Has Placebo Group · N/A

FFC-AC-EIT
Behavioral
Experimental Group · 1 Intervention: FFC-AC-EIT · Intervention Types: Behavioral
Education Only
Behavioral
PlaceboComparator Group · 1 Intervention: FFC-AC-EIT · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: number of er visits in the 1st month post discharge; number of er visits between the 1st month to 6th month post discharge; number of er visits between 6th and 12th months post discharge

Who is running the clinical trial?

Penn State UniversityOTHER
333 Previous Clinical Trials
120,631 Total Patients Enrolled
12 Trials studying Dementia
2,522 Patients Enrolled for Dementia
University of Maryland, BaltimoreLead Sponsor
635 Previous Clinical Trials
357,429 Total Patients Enrolled
7 Trials studying Dementia
1,922 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,148 Total Patients Enrolled
233 Trials studying Dementia
921,714 Patients Enrolled for Dementia
Barbara Resnick, PhDPrincipal Investigator - University of Maryland
University of Maryland, Baltimore

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a mild to moderate level of dementia, as measured by the Clinical Dementia Rating Scale (CDR) score of 0.5 to 2.0.

Frequently Asked Questions

Are there multiple locations through which the trial is being conducted within this state?

"Currently, 4 locations are enrolling patients in this clinical trial. These include Towson and Perryville, Philadelphia, as well as two other sites. To reduce the burden of travel when participating in the study it is recommended to select a clinic closest to you." - Anonymous Online Contributor

Unverified Answer

How many participants is the clinical trial enrolling?

"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is currently in progress; the trial was first posted on 19th October 2020 and last updated on 3rd October 2022. 600 participants are needed across 4 locations." - Anonymous Online Contributor

Unverified Answer

Are new participants being taken for this research endeavor?

"Per the information hosted on clinicaltrials.gov, enrollment for this study is still ongoing; it was originally listed on October 19th 2020 and its details were last updated October 3rd 2022." - Anonymous Online Contributor

Unverified Answer

What are the ultimate aims of this experiment?

"With the primary outcome of this trial being evaluated according to The Confusion Assessment Method, secondary objectives include monitoring new nursing home admissions, falls and emergency room visits over a span of one year. This study will measure change from baseline (upon hospital admission) up until hospital discharge (approximately 3 days), with further measurement at 1, 6 and 12 months post-discharge." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.