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Function Focused Care for Dementia

N/A

Recruiting

Led By Barbara Resnick, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted onto a medical unit for any medical diagnosis

Patients admitted into the hospital from any setting during the 12 month implementation period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

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.

Who is the study for?

This trial is for hospitalized patients aged 55 or older who have dementia, as indicated by certain test scores and functional impairment. They must be newly admitted to a medical unit and not enrolled in hospice, anticipating surgery, or dealing with major psychiatric or significant neurological conditions other than dementia.Check my eligibility

What is being tested?

The study tests Function Focused Care for Acute Care (FFC-AC-EIT), which encourages physical activity among older adults with dementia during hospital stays. It compares this approach against basic function-focused care education in hospitals across Maryland and Pennsylvania.See study design

What are the potential side effects?

Since the intervention focuses on increasing physical activity through nursing care rather than medication, traditional side effects are not expected. However, there may be risks associated with increased activity such as fatigue or falls.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently admitted to a hospital for a medical condition.

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I have been admitted to the hospital at least once in the last year.

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I am 55 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Barthel Index

Delirium Rating Scale

Motionwatch8 data

+5 more

Secondary outcome measures

Emergency room (ER) visits

Falls

hospitalizations

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FFC-AC-EITExperimental Treatment1 Intervention

The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of FFC-AC-EIT [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized.

Group II: Education OnlyPlacebo Group1 Intervention

Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Penn State UniversityOTHER

355 Previous Clinical Trials

125,157 Total Patients Enrolled

14 Trials studying Dementia

3,680 Patients Enrolled for Dementia

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,056 Total Patients Enrolled

8 Trials studying Dementia

3,687 Patients Enrolled for Dementia

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,325 Total Patients Enrolled

268 Trials studying Dementia

23,627,006 Patients Enrolled for Dementia

Media Library

FFC-AC-EIT Clinical Trial Eligibility Overview. Trial Name: NCT04235374 — N/A

Dementia Research Study Groups: FFC-AC-EIT, Education Only

Dementia Clinical Trial 2023: FFC-AC-EIT Highlights & Side Effects. Trial Name: NCT04235374 — N/A

FFC-AC-EIT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235374 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation of Function Focused Care in Acute Care

Barbara Resnick 2020. "Implementation of Function Focused Care in Acute Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04235374.

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