Function Focused Care for Dementia

No longer recruiting at 13 trial locations

Overseen By barbara resnick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Hospice, Surgery, Major psychiatric, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to care for hospitalized patients with dementia, focusing on encouraging physical activity, such as moving around or basic self-care, to prevent issues like falls and delirium. The trial compares two groups: one receiving a comprehensive support plan for staying active (called FFC-AC-EIT) and another receiving basic education. Suitable candidates for this trial are those aged 55 or older, admitted to the hospital, and have mild to moderate dementia with some functional difficulties. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for dementia patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing physical activity for patients with dementia during hospitalization.

What prior data suggests that this method is safe for patients with Alzheimer's Disease and Related Dementias?

Research has shown that Function Focused Care for Acute Care (FFC-AC-EIT) is generally safe for older adults with Alzheimer's and similar dementias. In past studies, patients using this care approach became more physically active and improved their abilities without major safety issues.

This care model helps patients stay active during hospital stays, reducing the risk of problems like sudden confusion (delirium) and falls. While data does not indicate specific negative effects from FFC-AC-EIT, the program aims to prevent issues rather than cause them.

Overall, FFC-AC-EIT is well-received, as it primarily involves nurses and caregivers supporting patients to move and stay active. This approach seeks to improve patient health by keeping them engaged and active during their hospital stay. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Function Focused Care for Dementia trial because it explores a comprehensive approach to enhancing the care of patients with Alzheimer's Disease and Related Dementias (ADRD). Unlike standard treatments that primarily focus on medication management, this trial investigates a method that combines environmental and policy assessments, education, goal-setting, and the mentoring of staff, patients, and families. This holistic approach could lead to improved patient engagement and outcomes by promoting physical activity and personalized care goals within hospital settings. Additionally, the integration of motivational "Tidbits" through weekly emails offers ongoing support and reinforcement for the care team, distinguishing it from traditional care practices.

What evidence suggests that the FFC-AC-EIT method is effective for improving physical activity and function in patients with Alzheimer's Disease and Related Dementias?

Research has shown that Function Focused Care for Acute Care using the Evidence Integration Triangle (FFC-AC-EIT), which participants in this trial may receive, can improve outcomes for patients with Alzheimer's Disease and Related Dementias (ADRD). Studies have found that this approach encourages physical activity, leading to better physical function, less pain, and fewer falls. It also helps reduce symptoms like confusion and behavioral issues. Evidence suggests that patients involved in FFC-AC-EIT spend less time in the hospital and have fewer unexpected return visits. This care model focuses on teaching and motivating patients and staff to stay active, which is linked to these positive results. ^{2 6 7 8 9}

Who Is on the Research Team?

Barbara Resnick, PhD

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

If you have memory problems and trouble with daily tasks, you might not be able to join the study.

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

Exclusion Criteria

I am expecting to have surgery.

I do not have a major psychiatric disorder or significant neurological condition affecting my thinking, other than dementia.

You are receiving end-of-life care in a hospice.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of FFC-AC-EIT with stakeholder meetings and intervention activities

12 months

Monthly meetings, weekly emails

Follow-up

Participants are monitored for outcomes such as hospitalizations, ER visits, and nursing home admissions

12 months

What Are the Treatments Tested in This Trial?

Interventions

• FFC-AC-EIT

Trial Overview

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.

How Is the Trial Designed?

Group I: FFC-AC-EIT Experimental Treatment 1 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 Only Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Family-centered Function-focused Care (Fam-FFC) significantly improved the likelihood of hospitalized patients with dementia returning to their baseline physical function, with a twofold increase compared to the control group over 6 months.

Fam-FFC also led to a reduction in behavioral symptoms of distress, indicating its potential effectiveness in enhancing the overall well-being of both patients and their family care partners during and after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an Intervention to Improve Posthospital Outcomes in Persons Living With Dementia and Their Family Care Partners. Boltz, M., Mogle, J., Kuzmik, A., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9064936/

Testing Function Focused Care for Acute Care Using the ...

The intent of this study is to determine if FFC-AC-EIT can be implemented and is successful in achieving positive clinical outcomes for patients in 12 hospitals ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39729078/

Implementation of Function Focused Care for Acute ... - PubMed

The purpose of this study was to test the impact of Function Focused Care for Acute Care Using the Evidence Integration Triangle (FFC-AC-EIT) on hospitalized ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1002/nur.22223

Testing Function Focused Care for Acute Care using the ...

This manuscript provides the protocol for a National Institute of Aging-funded cluster randomized clinical trial that focuses on helping nurses in acute care.

4.

researchgate.net

researchgate.net/publication/376725343_FUNCTION-FOCUSED_CARE_FOR_ACUTE_CARE_USING_THE_EVIDENCE_INTEGRATION_TRIANGLE_IMPACT_OF_PATIENT_CARE_ACTIVITIES

function-focused care for acute care using the evidence ...

Function focused care helps nurses to evaluate patient's underlying physical capability and motivate them to participate in all care activities.

5.

pure.psu.edu

pure.psu.edu/en/projects/testing-the-efficacy-of-ffc-ac-eit-in-patients-with-alzheimers-di-4

Testing the Efficacy of FFC-AC-EIT in Patients with ...

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 ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/10541858

Testing the Efficacy of FFC-AC-EIT in Patients with ...

These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay.

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/74/NCT04235374/Prot_SAP_000.pdf

Testing the Efficacy of FFC-AC-EIT in Patients with Alzheimer's ...

Sample and Setting: Twelve hospitals (six in Maryland and six in Pennsylvania) will be randomized to treatment (FFC-AC-EIT) or Education-Only (EO) using ...

8.

researchgate.net

researchgate.net/publication/387469478_Implementation_of_Function_Focused_Care_for_Acute_Care_Using_the_Evidence_Integration_Triangle

Implementation of Function Focused Care for Acute ...

Outcome measures included the Barthel Index; the Physical Activity Survey, the Confusion Assessment Method Short Form (CAM‐S), the Neuropsychiatric Inventory ( ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S152490422500027X

Factors Associated With Pain Among Hospitalized Older ...

This was a secondary data analysis using data from the Function Focused Care for Acute Care Using the Evidence Integration Theory (FFC-AC-EIT) study to increase ...