A Family-centered Intervention for Acutely-ill Persons With Dementia

NCT03046121 | Completed Results DMC

• 1 other identifier: R01AG054425
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 3

Brief Summary

This study will address the effectiveness of Family-centered Function Focused Care (Fam-FFC). Fam-FFC is a theoretically-based approach to care in which family caregivers partner with nurses to prevent functional decline and other complications related to hospitalization in older adults with Alzheimer's disease and related dementias. A systematic care pathway promotes information-sharing and decision-making that promotes physical activity, function, and cognitive stimulation during the hospitalization and immediate post-acute period. Our goal in this work is to establish a practical and effective way to optimize function and physical activity; decrease neuropsychiatric symptoms, delirium, and depression; prevent avoidable post-acute care dependency; and prevent unnecessary rehospitalizations and long-stay nursing home admissions, while mitigating family caregiver strain and burden.

Conditions

Alzheimer Disease

Keywords

dementia; acute care; post-acute recovery; family caregivers

Outcome Measures

Primary Outcomes (2)

• Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge).

  Assessed using the Barthel Index, comparing the change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge. Return to baseline physical function (yes/no) was scored as yes if the participant's functional status was the same as baseline, within five points or less than baseline, or greater than baseline. Scores ranged from 0 to 1, with higher scores representing better outcomes.

  Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge

• Caregiver Preparedness

  Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness.

  Discharge and 2 and 6 months post-discharge

Secondary Outcomes (10)

• Delirium Severity

  Admission, Discharge, 2 and 6 months post-discharge

• Behavior

  Admission, Discharge, 2 and 6 months post-discharge

• Moderate Physical Activity Level

  admission, discharge, 2 and 6 months post-discharge

• Depression

  admission, discharge, 2 and 6 months post-discharge

• Caregiver Strain

  Discharge and 2 and 6 months post-discharge

Other Outcomes (1)

• Health Care Cost

  end of intervention at each study site, 12 months after enrollment initiated

Study Arms (2)

Fam-FFC

EXPERIMENTAL

The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan.

Behavioral: Family-centered Function-focused Care (Fam-FFC)

Attention Control (Fam- FFC Ed-only)

NO INTERVENTION

Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).

Interventions

Family-centered Function-focused Care (Fam-FFC) BEHAVIORAL

An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.

Fam-FFC

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• Staff nurses (at the conclusion of the intervention at each site) who identify the intervention unit as the primary unit worked, and speak English or Spanish, will be included in focus groups
• For the exploratory aim of assessing the cultural appropriateness of the intervention, we will recruit family caregivers who self-identify as black, Latino, Asian and white, randomly selected from the Fam-FFC sample. Approximately 10 percent of families from each ethnic group represented in the study will be approached for consent for participation in interviews. (If theoretical saturation is not reached, interviews will continue until saturation is reached). Additionally, the six nurse champions will be consented and interviewed after the study ends in his/her particular unit/setting to provide their perspective on the cultural appropriateness of Fam-FFC.

Sponsors & Collaborators

• Penn State University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Lancaster General Medical Center

Lancaster, Pennsylvania, 17602, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (4)

• Kuzmik A, Best I, Al Harrasi AM, Boltz M. Mediating role of care partner burden among dementia care partners during post-hospital transition. Aging Ment Health. 2024 Dec;28(12):1753-1759. doi: 10.1080/13607863.2024.2370441. Epub 2024 Jun 25.

  PMID: 38915264 DERIVED

• Kuzmik A, BeLue R, Resnick B, Rodriguez M, Berish D, Galvin JE, Boltz M. Caregiver preparedness is associated with desire to seek long-term care admission of hospitalized persons with dementia. Int J Geriatr Psychiatry. 2023 Sep;38(9):e6006. doi: 10.1002/gps.6006.

  PMID: 37715936 DERIVED

• Paudel A, Ann Mogle J, Kuzmik A, Resnick B, BeLue R, Galik E, Liu W, Behrens L, Jao YL, Boltz M. Gender differences in interactions and depressive symptoms among hospitalized older patients living with dementia. J Women Aging. 2023 Sep-Oct;35(5):476-486. doi: 10.1080/08952841.2022.2146972. Epub 2022 Nov 26.

  PMID: 36433792 DERIVED

• Boltz M, Kuzmik A, Resnick B, Trotta R, Mogle J, BeLue R, Leslie D, Galvin JE. Reducing disability via a family centered intervention for acutely ill persons with Alzheimer's disease and related dementias: protocol of a cluster-randomized controlled trial (Fam-FFC study). Trials. 2018 Sep 17;19(1):496. doi: 10.1186/s13063-018-2875-1.

  PMID: 30223870 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study was limited by geographic location and attrition due to deaths which is common in this population.

Results Point of Contact

• Title: Marie Boltz PhD
• Organization: Penn State University

mpb40@psu.edu

215-962-9712

Study Officials

• Marie Boltz, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 8, 2017
• Study Start: November 6, 2017
• Primary Completion: February 28, 2022
• Study Completion: December 23, 2023
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)