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.


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:, ID: NCT03046121 . Registered on 8 February 2017.

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

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adaptation, Psychological
  • Aged
  • Alzheimer Disease / diagnosis
  • Alzheimer Disease / physiopathology
  • Alzheimer Disease / psychology
  • Alzheimer Disease / therapy*
  • Caregivers / psychology*
  • Cognition
  • Cost of Illness
  • Family Relations
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Male
  • Memory
  • Multicenter Studies as Topic
  • New England
  • Patient Care Planning / organization & administration*
  • Patient-Centered Care / organization & administration*
  • Power, Psychological*
  • Professional-Family Relations
  • Randomized Controlled Trials as Topic
  • Recovery of Function
  • Time Factors
  • Treatment Outcome

Associated data