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CHW Home Visit + Wearable Tech for Dementia Caregivers
N/A
Recruiting
Led By Jung-Ah Lee, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether a 3-month, in-home intervention delivered by a community health worker, using wearable technology to monitor stress and sleep, can help reduce stress and improve wellbeing for caregivers of people with dementia.
Who is the study for?
This study is for family caregivers of people with dementia who are primary care providers. Participants must be Korean, Vietnamese, Latino/Hispanic, or non-Hispanic Whites and speak English, Spanish, Vietnamese, or Korean. They should agree to wear a smartwatch during the day and a smartring at night for 3 months.Check my eligibility
What is being tested?
The trial tests a home visit intervention by community health workers offering stress reduction techniques and caregiving education versus usual care. It includes wearable technology to monitor caregiver stress and sleep in real-time over three months.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve supportive techniques rather than medical treatments; however, wearing monitoring devices could cause discomfort or skin irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver Burden
Caregiver Depression
Secondary outcome measures
Caregiver Sleep Quality
Caregiver's Perceived Stress
Caregiving Self-Efficacy
+4 moreOther outcome measures
Dementia care services utilization
Physical Activity
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Home visit intervention by community health workersExperimental Treatment1 Intervention
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.
Group II: Attention Control with wearable smartwatch/ringActive Control1 Intervention
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.
Group III: Usual Care GroupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
543 Previous Clinical Trials
1,922,669 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,731 Total Patients Enrolled
Jung-Ah Lee, PhDPrincipal Investigator - Associate Professor
University of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I require hospice care.I am currently receiving treatment for my cancer.I am a relative of someone with dementia living at home.I am the main caregiver for someone with dementia.I am over 65 and can understand and consent to medical procedures.I identify as Korean, Vietnamese, Latino/Hispanic, or non-Hispanic White and speak English, Spanish, Vietnamese, or Korean.
Research Study Groups:
This trial has the following groups:- Group 1: Home visit intervention by community health workers
- Group 2: Attention Control with wearable smartwatch/ring
- Group 3: Usual Care Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients still able to join this trial?
"This trial, which was first announced on May 19th 2021, is still recruiting patients as of April 15th 2022 according to the listings on clinicaltrials.gov"
Answered by AI
How many volunteers are included in this experiment?
"Yes, this is an ongoing study that has recently been updated. According to the information found on clinicaltrials.gov, the trial was posted on May 19th 2021 and last updated on April 15th 2022. They are looking for a total of 332 participants from 1 site."
Answered by AI
What are the objectives of this research project?
"The primary outcome of this clinical trial is Caregiver Depression, which will be monitored over a period of six months. Secondary outcomes include Sleep quality and Perceived behavioral problems of PWD, both of which will be measured over a three-month period. Additionally, the study will measure Caregiver's Perceived Stress levels."
Answered by AI
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