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Clinical Trial Summary

Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD, called CareHeroes (CH). A clinical trial will be conducted to evaluate outcomes of 120 triads (PWD/caregivers/providers) utilizing the CH intervention as an adjunct to care and caregiving for 12 months.


Clinical Trial Description

The target enrollment for the clinical trial is 120 triads of health care providers, caregivers, and people with dementia (PWD), where 120 unique dyads of caregivers/PWD will participate and healthcare providers will participate in multiple triads. The team plans to enroll 60 triads at each of the two participating clinical sites. Participants will be randomly assigned to either the full intervention or a minimal intervention for a period of 12 months, where they will be asked to communicate clinical and other relevant information with one another as part of regular caregiving and clinical care activities. Several psychosocial outcome variables for providers, caregivers, and PWD will be assessed. We will compare outcomes based on group assignment and different amounts and patterns of use of CH (e.g., minimal/non-users versus frequent users). The primary outcome variables are quality of life for caregivers and PWD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04571502
Study type Interventional
Source Florida International University
Contact Ellen L Brown, EdD,RN,FAAN
Phone 305-348-1312
Email ebrown@fiu.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date May 31, 2025

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