Clinical trial NCT04894006: Dementia Family Caregiver Study
Official title: A Home-based, Culturally and Language Specific Intervention for Dementia Family Caregivers: Stress Reduction and Education With Wearable Technology for Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Caregiver
Keywords: Caregiver Burden
Caregiver Stress
Caregiver Self-Efficacy
Caregiver Sleep
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-05-20
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community health worker (CHW) delivered home visit, culturally and language-appropriate intervention for ethnic and underserved dementia family caregivers of persons with dementia (PWD). 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Burden
timeFrame: 6 months
measure: Caregiver Depression
timeFrame: 6 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 6 months
measure: Caregiving Self-Efficacy
timeFrame: 6 months
measure: Perceived behavioral problems of PWD
timeFrame: 6 months
measure: Stress
timeFrame: 3 months
measure: Sleep quality
timeFrame: 3 months
measure: Caregiver's Perceived Stress
timeFrame: 6 months
measure: Caregiver Sleep Quality
timeFrame: 6 months
Other outcomes:
measure: Dementia care services utilization
timeFrame: 6 months
measure: Physical Activity
timeFrame: 3 months
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: Associate Professor
name: Jung-Ah Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nguyen H, Zaragoza M, Wussler N, Lee JA. "I was Confused About How to Take Care of Mom Because this Disease is Different Everyday": Vietnamese American Caregivers' Understanding of Alzheimer's Disease. J Cross Cult Gerontol. 2020 Jun;35(2):217-234. doi: 10.1007/s10823-020-09396-7.
citation: Ta Park VM, Ton V, Yeo G, Tiet QQ, Vuong Q, Gallagher-Thompson D. Vietnamese American Dementia Caregivers' Perceptions and Experiences of a Culturally Tailored, Evidence-Based Program to Reduce Stress and Depression. J Gerontol Nurs. 2019 Sep 1;45(9):39-50. doi: 10.3928/00989134-20190813-05.
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