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. 2018 Sep 17;19(1):496.
doi: 10.1186/s13063-018-2875-1.

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)

Marie Boltz  1 , Ashley Kuzmik  2 , Barbara Resnick  3 , Rebecca Trotta  4 , Jacqueline Mogle  2 , Rhonda BeLue  5 , Douglas Leslie  2 , James E Galvin  6
Affiliations

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)

Marie Boltz et al. Trials. .

Abstract

Background: Hospitalized older persons with Alzheimer's disease and related dementias are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, environmental, policy, and care practices that restrict physical and cognitive activity, lack of family involvement and limited staff knowledge of dementia care. We have developed a theory-based intervention, Family centered Function-focused Care, that incorporates an educational empowerment model for family caregivers (FCGs) provided within a social-ecological framework to promote specialized care to patients with dementia during hospitalization and the 60-day post-acute period. Primary aims are to test the efficacy of the intervention in improving physical and cognitive recovery in hospitalized persons living with Alzheimer's disease and related dementias (ADRD) and improving FCG preparedness and experiences.

Method: We will implement Family centered Function-focused Care in a cluster-randomized trial of 438 patient/FCG dyads in six hospital units randomized within three hospitals. We hypothesize that patients who receive the intervention will demonstrate better physical function, less delirium occurrence and severity, neuropsychiatric symptoms, and depression compared to those in the control condition (Education-only). We also hypothesize that FCGs enrolled in Family centered Function-focused Care will experience increased preparedness for caregiving, and less strain, burden, and desire to institutionalize, as compared to FCGs the control group. We will also examine the costs and relative cost savings associated with the intervention and will evaluate the cultural appropriateness of Family centered Function-focused Care for families from diverse backgrounds.

Discussion: Our theory-based intervention makes use of real-world applicable approaches in a novel and innovative way to change the paradigm of how we currently look at acute care and post-acute transitions in persons with ADRD.

Trial registration: ClinicalTrials.gov, ID: NCT03046121 . Registered on 8 February 2017.

Keywords: Dementia; Family engagement; Functional recovery; Hospitalization; Post-acute.

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Conflict of interest statement

Ethics approval and consent to participate

The Fam-FFC study was approved by the Pennsylvania State University Institutional Review Board on 9 February 2017 (Study #:00006201). Any proposed modifications to the protocol will be submitted to the IRB for approval, and ClinicalTrials and participants apprised when indicated. Authors will have access to the final trial dataset. We will actively disseminate the findings of the proposed research via standard peer review mechanisms including the submission of abstracts for poster and podium presentations at local, regional, national, and international scientific meetings. We will prepare summary findings for key NIH staff as requested for inclusion in relevant reports. We plan to prepare and submit manuscripts for publication in geriatric/gerontological, behavioral health, and medical journals. As is customary, findings will also be presented to lay audiences following appropriate peer review.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Social Ecological Model: factors influencing functional recovery in hospitalized persons with dementia
Fig. 2
Fig. 2
Overall schedule and time commitment for trial participants
See this image and copyright information in PMC

References

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