Dementia Family Caregiver Study

Not Applicable

Recruiting

• Conditions: Dementia Caregiver

• Registration Number: NCT04894006
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Over 5.8 million Americans are living with Alzheimer's dementia, a disease with no effective treatment and no cure. Two-thirds of the caregivers for persons with dementia (PWD) are women (most often family) and a third are themselves over 65. Dementia takes a significant toll on caregivers, often resulting in chronic stress, depression, sleep disorders, poor health related quality of life (HRQOL), and early mortality due 24/7 care responsibility for PWD. Research has shown significant barriers to dementia care for underserved populations, including Latinos and Asian minorities. Underserved family caregivers for PWD tend to underutilize public health services available, and do not seek treatment until the situation is unmanageable with current resources reporting barriers that included language, time, and finances. Monitoring the caregiver's health and wellbeing is important as well as their maintaining a positive interaction with the PWD. Thus, there is a need for an innovative and feasible intervention to improve underserved caregiver's mental and physical health. Little research is reported for dementia caregiver interventions in underserved minorities and one given at home by community health workers (CHWs). The proposed intervention meets the needs of these family caregivers in developing a positive relationship with the PWD by educating caregivers to better understand the PWD's behaviors. Another component of the intervention is stress reduction techniques, including mindful breathing and compassionate support/listening to reduce depression and improve family relationships making the caregiving less burdensome. By monitoring the physiological responses of stress (i.e. heart rate variability), sleep and activity, we can objectively measure changes as a result of the intervention. Using Wearable Internet of Things (WIoT) technology, a combination of Watch/ring-Smartphone-Cloud, has proven to be a significant method of monitoring behavioral and physiological measures providing evidence of change over time uniquely associated with this intervention. Our preliminary data show that the intervention with WIoT brought to the caregiver by CHW home visitors was acceptable to ethnic caregivers (Latino, Vietnamese, and Korean) and effective in reducing caregiver stress and burden over the short term. With the addition of non-Hispanic Whites, the proposed caregiver-centered, culturally/language appropriate, CHW home-visit-based 3-month intervention has 3 parts:1) stress reduction by mindful breathing and compassionate support/ listening to improve caregiver's health and well-being; 2) education on caregiving skills to improve responses to the PWD and their behaviors; 3) WIoT physiological and behavioral monitoring. This randomized controlled trial will compare outcomes (burden, depression, self-efficacy, HRQOL, stress, sleep, PWD behaviors) between the intervention, attention control with use of WIoT only, and usual care groups at baseline, 3 months, and 6 months. This intervention using the CHW-model and WIOT technology has the potential to lessen health disparities in dementia caregiving in underserved family caregivers.

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-15
• Study Start: 2021-05-19
• Study First Posted: 2021-05-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-03-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• other significant health problems (i.e., having pacemaker, epilepsy or neurologic disorder) that exclude wearing a smartwatch and a smartring

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caregiver Depression	6 months	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.
Caregiver Burden	6 months	The Zarit Burden Interview will be used to evaluate dementia informal caregiver burden three times throughout the study to assess changes in caregiver burden.

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	6 months	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.
Caregiver Sleep Quality	6 months	The sleep quality of caregivers will be measured by the Pittsburgh Sleep Quality Index (PSQI). PSQI is a questionnaire that assesses seven component scores; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Perceived behavioral problems of PWD	6 months	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
Stress	3 months	Caregivers' stress quality will be measured by wearable Internet of Things (WIoT) technology, a combination of Smartwatch/ring-Smartphone-Clo ud for 3 months.
Caregiving Self-Efficacy	6 months	The revised self-efficacy with 3 domains of caregiving self-efficacy: Obtaining respite, Responding to disruptive behaviors of PWD, and controlling upsetting thoughts.
Sleep quality	3 months	Caregivers' sleep quality will be measured by WIoT technology, smartring-Smartphone-Cloud for 3 months. The smart ring will report sleep quality and duration: length, quality (REM, Deep, and Light), disruptions in sleep, movement during sleep, awakes times, sleep latency, time in bed, sleep efficiency, sleep score.
Caregiver's Perceived Stress	6 months	The Perceived Stress Scale (PSS) that measures the appraisal of general stress in one's life, interpreting that higher scores indicate higher stress.

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States