Dementia Family Caregiver Study

July 6, 2026 updated by: Jung-Ah Lee, University of California, Irvine

A Home-based, Culturally and Language Specific Intervention for Dementia Family Caregivers: Stress Reduction and Education With Wearable Technology for Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
332

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jung-Ah Lee, PhD
  • Phone Number: (949) 824-2855
  • Email: jungahl@uci.edu

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Community Health Worker (CHW) Home Visit Intervention
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.
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.
Behavioral: Attention Control Group with WIoT Technology
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.
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.
Behavioral: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caregiver Burden
Time Frame: 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.
6 months
Caregiver Depression
Time Frame: 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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life
Time Frame: 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.
6 months
Caregiving Self-Efficacy
Time Frame: 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.
6 months
Perceived behavioral problems of PWD
Time Frame: 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
6 months
Stress
Time Frame: 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.
3 months
Sleep quality
Time Frame: 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.
3 months
Caregiver's Perceived Stress
Time Frame: 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.
6 months
Caregiver Sleep Quality
Time Frame: 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.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dementia care services utilization
Time Frame: 6 months
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.
6 months
Physical Activity
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jung-Ah Lee, PhD, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20206027
  • 1R01AG069074-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings