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Clinical Trials/NCT04571502
NCT04571502
Enrolling By Invitation
Not Applicable

Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care

Florida International University2 sites in 1 country58 target enrollmentFebruary 7, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurocognitive Disorders
Sponsor
Florida International University
Enrollment
58
Locations
2
Primary Endpoint
Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)
Status
Enrolling By Invitation
Last Updated
9 months ago

Overview

Brief 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. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.

Detailed Description

The target enrollment for the clinical trial is 58 dyads of caregivers and people with dementia (PWD), where 58 unique dyads of caregivers/PWD will participate. The team plans to enroll a total of 58 dyads across two participating clinical sites. Participants will be randomly assigned to either the full intervention or a control condition for a period of 6 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 the MyPATI (e.g., minimal/non-users versus frequent users). The primary outcome variables are quality of life for caregivers and PWD. The research team will recruit an estimated 15 healthcare providers across both sites at the end of study to assess their experience with My PATI using open and closed ended queries.

Registry
clinicaltrials.gov
Start Date
February 7, 2025
End Date
January 6, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)

Time Frame: Baseline, 3-months, 6- months

The 13-item QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the care recipient's physical health, mood, relationships, activities, and ability to complete tasks. The Care Recipient (self-assesses) and caregiver (proxy-interview) complete the QOL-AD.

Change in Perceived Change Index- Caregiver QOL

Time Frame: Baseline, 3-months, 6- months

A 13-item scale that measures caregiver appraisals of self-improvement or decline in distinct areas of well- being. Caregiver indicates whether each item has become worse, stayed the same, or improved in the past month: feeling rested, ability to have time for yourself, and feelings of being upset. The total and subscales (Affect, Somatic, and Ability to Manage)

Secondary Outcomes

  • Change in Oberved PHQ-9 Caregiver Interviewed about Care Recipient(Baseline, 6-months)
  • Change in PATIENT HEALTH QUESTIONNAIRE (PHQ-9)- Caregiver(Baseline, 3-months, 6- months)
  • Change in The Positive Aspects of Caregiving Scale- Caregiver(Baseline, 3-months, 6- months)
  • Change in Zarit Caregiver Burden Inventory-22 items (ZBI-22)- Caregiver(Baseline, 3-months, 6-months)
  • Change in 12 Item Short-Form Health Survey (SF-12) - Caregiver(Baseline,6-months)
  • Change in The Revised Memory and Behavior Problems Checklist - Caregiver interviewed about Care Recipient(Baseline, 6-months)
  • Change in Geriatric Depression Scale (GDS-15)- Care Recipient(Baseline, 6-months)
  • Change in Partner-Patient Questionnaire for Shared Activities-Caregiver interviewed about relationship with Care Recipient(Baseline, 3 Months, 6 Months)
  • Change in Functional Linguistic Communication Inventory (FLCI)- Care Recipient(Baseline)
  • My PATI Usage - Links clicked on the app, resources accessed(6 months)
  • Provider Interviews(6 months)
  • My PATI Usage- Links clicked on the app, resources accessed(6 months)

Study Sites (2)

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