Dementia Family Caregiver Study

NCT04894006 | Recruiting

• 2 other identifiers: 202060271R01AG069074-01
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Caregiver

Keywords

Caregiver Burden; Caregiver Stress; Caregiver Self-Efficacy; Caregiver Sleep

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (7)

• Health Related Quality of Life

  6 months

• Caregiving Self-Efficacy

  6 months

• Perceived behavioral problems of PWD

  6 months

• Stress

  3 months

• Sleep quality

  3 months

Other Outcomes (2)

• Dementia care services utilization

  6 months

• Physical Activity

  3 months

Study Arms (3)

Home visit intervention by community health workers

EXPERIMENTAL

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.

Behavioral: Community Health Worker (CHW) Home Visit Intervention

Attention Control with wearable smartwatch/ring

ACTIVE COMPARATOR

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.

Usual Care Group

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

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.

Home visit intervention by community health workers

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.

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

Related Publications (9)

• Balbim GM, Marques IG, Cortez C, Magallanes M, Rocha J, Marquez DX. Coping Strategies Utilized by Middle-Aged and Older Latino Caregivers of Loved Ones with Alzheimer's Disease and Related Dementia. J Cross Cult Gerontol. 2019 Dec;34(4):355-371. doi: 10.1007/s10823-019-09390-8.

  PMID: 31705279 BACKGROUND

• Caceres BA, Perez A. Implications of the CARE Act for Latino Caregivers. J Gerontol Nurs. 2018 Mar 1;44(3):9-14. doi: 10.3928/00989134-20180213-04.

  PMID: 29470586 BACKGROUND

• Cheng ST, Lau RW, Mak EP, Ng NS, Lam LC. Benefit-finding intervention for Alzheimer caregivers: conceptual framework, implementation issues, and preliminary efficacy. Gerontologist. 2014 Dec;54(6):1049-58. doi: 10.1093/geront/gnu018. Epub 2014 Mar 31.

  PMID: 24688081 BACKGROUND

• Kenning C, Daker-White G, Blakemore A, Panagioti M, Waheed W. Barriers and facilitators in accessing dementia care by ethnic minority groups: a meta-synthesis of qualitative studies. BMC Psychiatry. 2017 Aug 30;17(1):316. doi: 10.1186/s12888-017-1474-0.

  PMID: 28854922 BACKGROUND

• Kim HJ, Kehoe P, Gibbs LM, Lee JA. Caregiving Experience of Dementia among Korean American Family Caregivers. Issues Ment Health Nurs. 2019 Feb;40(2):158-165. doi: 10.1080/01612840.2018.1534909. Epub 2019 Jan 8.

  PMID: 30620625 BACKGROUND

• Neary SR, Mahoney DF. Dementia caregiving: the experiences of Hispanic/Latino caregivers. J Transcult Nurs. 2005 Apr;16(2):163-70. doi: 10.1177/1043659604273547.

  PMID: 15764640 BACKGROUND

• 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.

  PMID: 32112183 BACKGROUND

• 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.

  PMID: 31437289 BACKGROUND

• Watari KF, Gatz M. Pathways to care for Alzheimer's disease among Korean Americans. Cultur Divers Ethnic Minor Psychol. 2004 Feb;10(1):23-38. doi: 10.1037/1099-9809.10.1.23.

  PMID: 14992628 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Jung-Ah Lee, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Ah Lee, PhD

CONTACT

(949) 824-2855; jungahl@uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Contact Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 20, 2021
• Study Start: May 19, 2021
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)