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Function Focused Care for Dementia

N/A
Waitlist Available
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
Must not have
Patients with a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia
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

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a major psychiatric disorder or significant neurological condition affecting my thinking, other than dementia.

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
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Barthel Index
Delirium Rating Scale
Motionwatch8 data
+5 more
Secondary study objectives
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.

Find a Location

Who is running the clinical trial?

Penn State UniversityOTHER
368 Previous Clinical Trials
127,136 Total Patients Enrolled
14 Trials studying Dementia
3,669 Patients Enrolled for Dementia
University of Maryland, BaltimoreLead Sponsor
711 Previous Clinical Trials
378,784 Total Patients Enrolled
8 Trials studying Dementia
3,687 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,183,638 Total Patients Enrolled
292 Trials studying Dementia
23,634,418 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
~18 spots leftby Jan 2025