Dementia Family Caregiver Study

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT04894006
Status
Recruiting

Conditions

  • Dementia Caregiver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Community Health Worker (CHW) Home Visit Intervention — BEHAVIORAL
    The on-site intervention will focus on stress reduction techniques and caregiving skills education for 4 weeks and two monthly caregiver-driven topics for the following two sessions. The education of dementia caregiving skills will include (1) understanding about Alzheimer's and dementias, (2) appropriate communication skills with PWD, (3) daily activities for or with PWD together (e.g., puzzles, writing, reading, singing, taking a walk, etc), and (4) care resources including support groups, adult day centers, or other dementia related social services (legal and financial matters). For stress reduction techniques to be effective, the investigators have installed an app on the smartwatch to remind them to practice mindful breathing exercises two times a day and when needed.
  • Attention Control Group with WIoT Technology — BEHAVIORAL
    The caregivers randomly assigned to the AC group will be asked to wear the smartwatch during the day time and the smartring during the night for 3 months in order to monitor their physiological measures (heart rate variability, heart rate, activities, and sleep quality). CHW will give AC participants an overview of WIOT instruction at the baseline home visit. Caregivers will also receive resource information regarding Alzheimer's association and local social service information. CHWs will contact them monthly via phone for 6 months answering general questions from participants. CHW will visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.
  • Usual Care — BEHAVIORAL
    The caregivers randomly assigned to UC group will receive resource information regarding Alzheimer's association and local social service information at the baseline home visit by CHW. CHWs will contact them monthly for 6 months by phone asking general questions from participants. CHWs will visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.

Study Details

The proposed study will test a 3-month, community health worker (CHW) delivered home visit, culturally and language-appropriate intervention for ethnic and underserved dementia family caregivers of persons with dementia (PWD) using wearable technology for real time monitoring of caregivers' stress and sleep. The CHW delivered home visit intervention includes stress reduction techniques by mindful deep breathing and compassionate support/listening and caregiving education to improve caregiver's health, wellbeing, and positive interactions with the PWD. This dementia caregiver study using wearable technology has the potential to significantly lessen health disparities in dementia care, assisting underserved ethnic dementia caregivers in self-management and increasing their quality of life.

Key Dates

Start date
May 19, 2021
Status verified
Apr 2025
Primary completion
Mar 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Home visit intervention by community health workers
    The caregiver-centered, culturally and language specific home visit intervention with wearable devices (smartwatch/ring) will be delivered by trained bilingual community health workers (CHW) for Latino, Vietnamese, Korean, non-Hispanic White caregivers of PWD. The home visit intervention components will include (1) stress reduction techniques; mindful breathing and compassionate support/listening and (2) weekly education on dementia caregiving skills to handle difficult behaviors of PWD and knowledge of resources available for dementia care. The duration of the intervention will be 12 weeks that include 6 home visits (4 times for the first month and then once a month for two months) carried out in the participant's home. The on-site home visit intervention delivered by CHWs will focus on stress reduction techniques and caregiving skills education for 4 weeks and two monthly caregiver-driven topics for the following two sessions.
  • Active Comparator: Attention Control with wearable smartwatch/ring
    The caregivers randomly assigned to the Attention Control (AC) group will be asked to wear smartwatch during the day time and smart ring during the night for 3 months in order to monitor their physiological measures (heart rate variability, heart rate, activities, sleep quality). CHW will give AC participants an overview of WIOT instruction at the baseline home visit. Caregivers will also receive resource information regarding Alzheimer's association and local social service information. CHWs will contact them monthly via phone for 6 months asking about the WIoT technology and answering general questions from participants. CHW will also visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.
  • Placebo Comparator: Usual Care Group
    The caregivers randomly assigned to Usual Care (UC) group will receive resource information regarding Alzheimer's association and local social service information at the baseline home visit by CHW. At recruitment, the participants will be told that at the end of the 6 months they will receive a smartwatch and a smartring for their participation. CHWs will contact them monthly for 6 months by phone answering only general questions from participants. CHW will also visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.

Primary Outcome Measure

Caregiver Burden [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Jung-Ah Lee, PhD
(949) 824-2855
Jung-Ah Lee, PhD (PRINCIPAL_INVESTIGATOR)
Amir Rahmani, PhD (PRINCIPAL_INVESTIGATOR)
Lisa Gibbs, MD (SUB_INVESTIGATOR)
Sanghyuk Shin, PhD (SUB_INVESTIGATOR)
Adey Nyamathi, PhD (SUB_INVESTIGATOR)

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