CHW Home Visit + Wearable Tech for Dementia Caregivers

Overseen By Jung-Ah Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Cognitive impairment, Chronic drug abuse, Cancer, others

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home visit program for caregivers of people with dementia. It aims to help caregivers manage stress and improve well-being through stress reduction techniques and education on caregiving skills. The study employs wearable technology, such as a smartwatch and ring, to monitor stress and sleep. It suits those who are primary caregivers for someone with dementia and belong to Latino, Vietnamese, Korean, or non-Hispanic White communities. Participants must be willing to wear the monitoring devices and have no major health issues that prevent their use. As an unphased trial, this study provides caregivers the opportunity to enhance their caregiving skills and well-being through innovative support methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on the use of wearable technology and does not mention medication changes.

What prior data suggests that this intervention is safe for dementia caregivers?

Research has shown that the Community Health Worker (CHW) Home Visit Program is generally safe for caregivers. In past studies, caregivers who participated in a 12-week home visit program led by CHWs reported positive experiences. This program focused on reducing stress and improving caregiving skills while respecting cultural needs. Although these studies highlighted the program's benefits, they did not identify any serious safety issues or negative effects. This suggests that participants handle the program well. However, as with any new program, ongoing monitoring is important to ensure safety for all involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines home visits by trained community health workers (CHWs) with wearable technology to provide personalized support for dementia caregivers. Unlike standard treatments, which often focus solely on providing information or medical interventions, this approach offers culturally and language-specific stress reduction techniques and caregiving skills education tailored to Latino, Vietnamese, Korean, and non-Hispanic White caregivers. The use of wearables like smartwatches and rings to monitor physiological responses adds a tech-forward element, allowing for real-time feedback and support. This blend of human interaction and technology aims to address both the emotional and practical challenges faced by caregivers, potentially leading to better outcomes for both caregivers and patients.

What evidence suggests that this trial's interventions could be effective for dementia caregivers?

Research has shown that home visits by community health workers (CHWs), which participants in this trial may receive, can benefit those caring for someone with dementia. One study found that caregivers who participated in a 12-week program of CHW-led home visits felt more supported and less stressed. The close relationship between CHWs and caregivers appears crucial to the program's success. This method may help caregivers manage stress and improve interactions with the person they care for. Another treatment arm in this trial involves using wearable devices to track stress and sleep, potentially enhancing these benefits by providing instant feedback and support. ^{1 2 3 6 7}

Who Is on the Research Team?

Jung-Ah Lee, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to wear monitoring devices (a smartwatch during daytime and a smartring during nighttime for 3 months)

I am a relative of someone with dementia living at home.

I am the main caregiver for someone with dementia.

Exclusion Criteria

I require hospice care.

Chronic drug abuse

I am currently receiving treatment for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Community health workers deliver a 3-month home visit intervention with stress reduction techniques, caregiving education, and wearable technology monitoring.

12 weeks

6 home visits (4 times in the first month, then once a month for two months)

Follow-up

Participants are monitored for outcomes such as caregiver burden, depression, and self-efficacy at baseline, 3 months, and 6 months.

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Extension

Participants in the Usual Care group receive wearable devices after 6 months for continued monitoring.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control Group with WIoT Technology
• Community Health Worker (CHW) Home Visit Intervention
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Home visit intervention by community health workers Experimental Treatment 1 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/ring Active Control 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

To cover the costs of a community health worker (CHW) program that addresses both medical and social needs, each CHW would need to help avoid nearly 50 emergency department visits per year for their caseload of 150 participants.

If participants also avoid 2 hospitalizations, the number of emergency visits needed to offset costs drops to about 34, suggesting that CHW programs can be cost-effective by reducing unnecessary healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where Is the Break-even Point for Community Health Workers? Using National Data and Local Programmatic Costs to Find the Break-even Point for a Metropolitan Community Health Worker Program. Gurley-Calvez, T., Williams, JAR.[2021]

A community health worker (CHW) intervention in Dar es Salaam, Tanzania, successfully identified over 43,000 pregnant women through more than 45,000 home visits, with over 75% of these women not having attended antenatal care (ANC) yet.

The program significantly reduced the median gestational age at which women were first contacted by CHWs, from 21/22 weeks to 16 weeks, indicating that CHWs can effectively reach women earlier in their pregnancies, which is crucial for improving ANC uptake and early HIV testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers to improve antenatal care and PMTCT uptake in Dar es Salaam, Tanzania: a quantitative performance evaluation. Lema, IA., Sando, D., Magesa, L., et al.[2020]

The community health worker (CHW) program helped 1600 frequent emergency department users in Buffalo, New York, achieve 43% of their health-related objectives, primarily focused on connecting clients to community resources and primary care.

Success in achieving these objectives was linked to higher client engagement with CHW services, indicating that improving access to resources and addressing systemic barriers could enhance the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers: Addressing Client Objectives Among Frequent Emergency Department Users. Kwan, BM., Rockwood, A., Bandle, B., et al.[2019]

Community health workers (CHWs) have proven effective in various health care settings, but their perceived value is diminished due to inconsistent credentialing and lack of billing structures for their services.

The article proposes a framework to better define CHW roles and competencies, which could help integrate them into health care systems and improve recognition and payment for their contributions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Framework to Describe Functions and Practice of Community Health Workers. Corder-Mabe, J., Johnson, S., Mazmanian, PE., et al.[2021]

The Strong Beginnings program successfully defined 28 specific interventions for community health workers (CHWs) to improve maternal and child health, categorized into seven core functions based on risk topics.

This structured approach not only enhances the clarity of the CHW role within healthcare teams but also promotes consistent care delivery and supports the sustainability of the program by linking CHW contributions to health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of the Community Health Worker within a Federal Healthy Start Care Coordination Team. Raffo, JE., Lloyd, C., Collier, M., et al.[2023]

Community health workers (CHWs) played a crucial role in a diabetes self-management intervention for low-income individuals, addressing barriers such as lack of diabetes knowledge, socioeconomic challenges, and healthcare system complexity through personalized education and support.

The study analyzed 634 encounter reports from 145 participants, highlighting that CHWs provided essential resources and guidance, demonstrating their effectiveness in improving diabetes management beyond what typical primary care can offer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. Silverman, J., Krieger, J., Sayre, G., et al.[2022]

In a study involving 1310 mother-infant pairs in rural Eastern Cape, home visits by community health workers (CHWs) led to important improvements in maternal health behaviors, such as increased antenatal visits and exclusive breastfeeding for 6 months (OR: 1.8).

Children of mothers who received CHW support were less likely to experience wasting (OR: 0.5) and had fewer symptoms of common childhood illnesses, indicating that while the effects were limited compared to urban settings, CHWs still play a beneficial role in rural health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers impact on maternal and child health outcomes in rural South Africa - a non-randomized two-group comparison study. le Roux, KW., Almirol, E., Rezvan, PH., et al.[2023]

A 15-hour training course significantly improved the asthma medication instruction abilities of 11 immigrant Mexican community health workers (CHWs), with median correct technique scores rising from 25% to 69% for metered dose inhalers and from 0% to 64% for spacers after training.

Post-training evaluations showed that all CHWs demonstrated adequate understanding of medication delivery techniques, indicating that with proper training, CHWs can effectively help families manage asthma medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an asthma medication training program for immigrant Mexican community health workers. Martin, MA., Mosnaim, GS., Rojas, D., et al.[2011]

In a focus group study with 24 low-income, uninsured adults from Project Access Dallas, participants highlighted that community health workers (CHWs) significantly help them navigate the healthcare system and improve their self-care abilities.

The findings suggest that integrating CHWs into a case management model effectively enhances patient understanding of health issues and supports underserved populations in managing their health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions of a community-based care coordination system. Gimpel, N., Marcee, A., Kennedy, K., et al.[2011]

An integrative review of 47 studies over 33 years found that Community Health Workers (CHWs) can significantly improve health outcomes for underserved populations through effective interprofessional teamwork with healthcare teams.

Out of the studies reviewed, four exemplified all five key assumptions of effective teamwork, highlighting the importance of shared roles, cooperation, and synergy in enhancing patient care, though more research is needed to fully understand these dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interprofessional Teamwork and Collaboration Between Community Health Workers and Healthcare Teams: An Integrative Review. Franklin, CM., Bernhardt, JM., Lopez, RP., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780965/

Community health workers supporting diverse family ... The present study thematically analyzed qualitative data from exit interviews with caregivers who participated in a CHW-led, 12-week home visit- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39558580/

Preliminary qualitative results from a randomized home-based ... Strong rapport between CHWs and caregivers enhanced the effectiveness of the intervention. Future approaches can focus on supporting caregivers ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04894006

NCT04894006 | Dementia Family Caregiver Study The proposed study will test a 3-month, community health worker (CHW) delivered home visit, culturally and language-appropriate intervention for ethnic and ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/287657

Dementia Family Caregiver Study The proposed study will test a 3-month, community health worker (CHW) delivered home visit, culturally and language-appropriate intervention ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT04894006

Dementia Family Caregiver Study The proposed study will test a 3-month, community health worker (CHW) delivered home visit, culturally and language-appropriate intervention ...

6. chwcentral.org chwcentral.org/resources/community-health-workers-supporting-diverse-family-caregivers-of-persons-with-dementia-preliminary-qualitative-results-from-a-randomized-home-based-study/

Community health workers supporting diverse family ... This study evaluated a 12-week home-visit program led by bilingual community health workers (CHWs) to support culturally diverse caregivers ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.