Dementia Family Caregiver Study

ConditionDementia Caregiver

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

a relative of community dwelling person with dementia (i.e., Alzheimer's Disease or related dementias)

providing primary care for the person with dementia

willing to wear monitoring devices (a smartwatch during day time and a smartring during night time for 3 months

self-reporting ethnicity/race as Korean, Vietnamese, Latino/Hispanic, or non-Hispanic Whites with the following languages spoken in this study: English, Spanish, Vietnamese, or Korean.

Disqualifiers

cognitive impairment that precludes an individual from understanding the consent process and completing surveys (for those aged 65 or older as assessed by Mini-Cog)

chronic drug abuse

currently active cancer treatment

need hospice care

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

332 Participants

are divided into 3 treatment groups

Group A: Home visit intervention by community health workersExperimental treatment 1 intervention

Group B: Attention Control with wearable smartwatch/ringActive comparator 0 interventions

Group C: Usual Care GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Caregiver Burden

The Zarit Burden Interview will be used to evaluate dementia informal caregiver burden three times throughout the study to assess changes in caregiver burden.

Time frame

6 months

Caregiver Depression

The Center for Epidemiologic Studies Depression Scale (CES-D) is a measure of depressive symptoms experienced in the previous week, with higher scores indicating more symptoms.

Time frame

6 months

Secondary outcomes

Health Related Quality of Life

The SF-12 Health Survey is a measure of health with the Physical Health Component Summary Score and Mental Health Component. Higher scores indicated better health.

Time frame

6 months

Caregiving Self-Efficacy

The revised self-efficacy with 3 domains of caregiving self-efficacy: Obtaining respite, Responding to disruptive behaviors of PWD, and controlling upsetting thoughts.

Time frame

6 months

Perceived behavioral problems of PWD

The Revised Memory and Behavior Problems Checklist (RMBPC) is a caregiver-report measure of behavioral problems of PWD providing 1 total score and 3 subscale scores for PWD problem (memory-related, depression, and disruptive behaviors) and parallel scores for caregiver reaction

Time frame

6 months

Stress

Caregivers' stress quality will be measured by wearable Internet of Things (WIoT) technology, a combination of Smartwatch/ring-Smartphone-Clo ud for 3 months.

Time frame

3 months

Other outcomes

Dementia care services utilization

The developed questionnaire will be used to identify caregiver's experience and utilization on dementia related care services publicly available including adult day services, in-home care services, support group, or other dementia related services/organization information.

Time frame

6 months

Physical Activity

Caregivers' physical activity will be measured by WIoT technology, smartwatch-Smartphone-Cloud for 3 months. The smartwatch will monitor physical activity: daily steps, distance, intensity minutes, floors climbed, and calories burned.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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