455 Participants Needed

Function Focused Care for Dementia

Recruiting at 13 trial locations
MB
br
Overseen Bybarbara resnick, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore

Trial Summary

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 data supports the effectiveness of the treatment FFC-AC-EIT for dementia?

The Function Focused Care interventions, like FFC-CI and Fam-FFC, have shown positive effects on improving function, physical activity, and reducing behavioral symptoms in dementia patients. These interventions engage caregivers and family members to help patients maintain their abilities and manage symptoms, suggesting that FFC-AC-EIT may also be effective in similar ways.12345

How is the Function Focused Care treatment for dementia different from other treatments?

Function Focused Care for dementia is unique because it involves training caregivers to actively engage patients in daily activities to improve their function and reduce behavioral symptoms, rather than relying on medication. This approach emphasizes physical activity and patient involvement, which can lead to better functional independence and fewer falls.12678

What is the purpose of this trial?

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.

Research Team

BR

Barbara Resnick, PhD

Principal Investigator

University of Maryland

Eligibility Criteria

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.
See 1 more

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
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 Clinic Near You

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+

Findings from Research

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.
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]

References

Testing an Intervention to Improve Posthospital Outcomes in Persons Living With Dementia and Their Family Care Partners. [2023]
Function Focused Care for Assisted Living Residents With Dementia. [2022]
A Cluster Randomized Controlled Trial Testing the Impact of Function and Behavior Focused Care for Nursing Home Residents With Dementia. [2022]
Testing the Impact of FFC-AL-EIT on Psychosocial and Behavioral Outcomes in Assisted Living. [2021]
Function-Focused Goal Attainment and Discharge Outcomes in Hospitalized Persons With Dementia. [2022]
Factors Associated With Function-Focused Care Among Hospitalized Older Adults With Dementia. [2023]
A pilot exploration of the effect of designated Function Focused Care on mobility, functional dependence and falls frequency in Dutch nursing home residents. [2018]
Functional decline in hospitalized older adults: can nursing make a difference? [2022]
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