Financial Education for Caregiver Burden

(CONFIDENCE-AI Trial)

Overseen By Kylie Meyer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Nursing home placement, Internet access, Language, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help caregivers manage financial stress by teaching cost-management strategies for caregiving. Participants attend four online group sessions to learn about budgeting, finding community resources, and seeking assistance. The trial employs the CONFIDENCE-AI program, which also offers support through an app with text messages and resource navigation. This trial targets Latino/Hispanic caregivers who have cared for someone with Alzheimer's or a similar condition for at least six months. Participants need reliable internet and a willingness to attend most sessions and use the app. As an unphased trial, this study offers caregivers the chance to acquire valuable skills and resources to alleviate their financial burden.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that the CONFIDENCE-AI intervention is safe?

Research has shown that financial education programs like CONFIDENCE-AI can boost caregivers' confidence and ease their stress. The main goal is to lower financial stress and improve money management skills. Delivered through Zoom and an app with AI, CONFIDENCE-AI does not cause physical side effects like medications or medical treatments.

The program is designed to be safe and supportive, focusing on improving financial well-being without risks. While past similar programs have not reported negative effects, participants can expect a safe environment centered on learning and resourcefulness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONFIDENCE-AI Program because it offers a fresh approach to easing caregiver burden through financial education. Unlike traditional support methods that may focus solely on emotional or physical support, this program equips caregivers with practical financial skills, teaching them how to budget and access community resources to reduce caregiving costs. The use of a digital app to enhance engagement and provide ongoing support is another innovative aspect that sets it apart, offering caregivers a convenient and interactive tool to manage their challenges effectively.

What evidence suggests that the CONFIDENCE-AI intervention is effective for reducing caregiver financial strain?

Research has shown that financial education programs, such as the CONFIDENCE-AI program studied in this trial, can ease caregivers' burdens by boosting confidence and reducing financial stress. Studies have found that these programs improve caregivers' ability to manage out-of-pocket care costs, leading to better resource use and less mental stress. Early results suggest that participating in structured sessions and using digital support, as offered in the CONFIDENCE-AI program, teaches practical financial management skills. These skills help caregivers feel more capable and supported in their roles. ^{1 2 3 6 7}

Who Is on the Research Team?

Kylie Meyer, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for self-identified caregivers of individuals diagnosed with Alzheimer's or related dementia at least 6 months ago, specifically those of Latino/Hispanic ethnicity. It aims to help them manage financial stress and improve their skills in handling care costs.

Inclusion Criteria

Latino/Hispanic ethnicity

I have been caring for someone with Alzheimer's or similar dementia for over 6 months.

Exclusion Criteria

Individuals who plan to place their family member in a nursing home in the next 3 months

Unreliable access to internet, tablet or smart phone, and email

Unable to read and speak in English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 4-week intervention including four synchronous group-based Zoom sessions and between-session activities.

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for changes in self-efficacy, financial strain, and resourcefulness post-intervention.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CONFIDENCE-AI

Trial Overview CONFIDENCE-AI is a program designed to reduce financial strain on caregivers through a 4-week course involving group Zoom sessions and activities between sessions. Caregivers will also use the NeuViCare AI app for tailored text messages and caregiving financial advice.

How Is the Trial Designed?

Group I: CONFIDENCE AI Experimental Treatment 1 Intervention

Participants will attend the 4-week CONFIDENCE-AI Program. This program will include attending 4 group-based sessions delivered by videoconference. Each session will last approximately 1.5 hours each and will cover topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, and more. Participation will be supplemented by access to a digital app to support engagement, such as through text messaging and resources navigation support.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Published Research Related to This Trial

Improving patient education is crucial for healthcare providers, especially for managing the health of chronically ill patients, as it is a cost-effective strategy.

Successful healthcare organizations should adopt best practices from leading providers to enhance their patient education systems, which can lead to better patient outcomes and organizational success in a competitive environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to improve patient education. Washburn, PV.[2007]

Internet-based supportive interventions significantly reduce depressive symptoms, perceived stress, anxiety, and improve self-efficacy among family caregivers of people with dementia, based on a systematic review of 17 randomized controlled trials.

These interventions also show potential benefits for care recipients, improving their quality of life and neuropsychiatric symptoms, suggesting a positive impact on both caregivers and those they care for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Supportive Interventions for Family Caregivers of People With Dementia: Systematic Review and Meta-Analysis. Leng, M., Zhao, Y., Xiao, H., et al.[2021]

The Zarit Caregiver Burden Scale, validated in Spanish, demonstrated strong internal reliability (Cronbach alpha of 0.92) and effectively measures caregiver burden, competency, and dependence in caregivers of Alzheimer's patients.

A Psychoeducational Intervention Program (PIP) significantly reduced the dependence burden in caregivers compared to standard care, particularly benefiting those with a Zarit scale score of 60 or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Martin-Carrasco, M., Otermin, P., Pérez-Camo, V., et al.[2022]

In 2004, around 44 million Americans were unpaid caregivers, contributing an estimated economic value of $306 billion, highlighting the significant impact of caregiving on society.

Women make up the majority of caregivers (61%) and often experience more negative mental and physical health outcomes compared to men, yet many still find caregiving to be a rewarding experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care needs of Americans: a major issue for women as both recipients and providers. McGuire, LC., Anderson, LA., Talley, RC., et al.[2007]

Patient education significantly improves compliance with therapeutic regimens in chronic disease management, with an average improvement of 0.67 sigma over control groups, indicating a strong effect.

While patient education also leads to improvements in physiological progress (0.49 sigma) and health outcomes (0.02 sigma), the most effective strategies involve behaviorally-oriented programs that focus on changing the patient's environment rather than just increasing knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? Mazzuca, SA.[2019]

Self-management education, which focuses on teaching problem-solving skills and enhancing self-efficacy, is more effective than traditional patient education in improving clinical outcomes for patients with chronic conditions.

Evidence suggests that self-management education can lead to better health outcomes and potentially lower healthcare costs, particularly for conditions like arthritis and asthma, indicating its importance in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient self-management of chronic disease in primary care. Bodenheimer, T., Lorig, K., Holman, H., et al.[2022]

A survey of 112 cancer caregivers revealed that both geriatric (≥65 years) and nongeriatric (18-64 years) caregivers have high access to technology, with 94% having Internet access and 91% using email.

Nongeriatric caregivers showed a greater willingness to use Internet-based tools and expected more benefits from technology, such as improved quality of life and reduced caregiver burden, indicating a potential area for targeted support in caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Caregiver: Perceived Benefits of Technology. Lapid, MI., Atherton, PJ., Clark, MM., et al.[2018]

Caregiver education programs can significantly improve knowledge about providing care for individuals with Huntington's disease, which initially leads to increased confidence and reduced stress for caregivers.

However, while knowledge gained from the training was retained over time, the improvements in caregiver confidence and stress levels did not last, indicating a need for ongoing support beyond initial education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational intervention for a Huntington's disease caregiver. Dura, JR.[2004]

Digital patient education in cardiology significantly enhances patient knowledge and health literacy, as evidenced by a review of 16 studies that utilized various digital platforms.

Patients who engaged with digital education reported improved quality of life and reduced levels of depression and anxiety, with high satisfaction rates for the digital platforms used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Digitalized Patient Education in Cardiology: A Future Ahead? Oudkerk Pool, MD., Hooglugt, JQ., Schijven, MP., et al.[2021]

Computer-based patient education has been shown to improve knowledge scores and clinical outcomes compared to traditional instruction, with 13 studies reporting positive results.

The review highlighted that 16 out of 21 research-based studies had significant effect sizes (greater than 0.5), indicating that computer-based education is an effective method for enhancing patient knowledge and skills, although more research is needed to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based approaches to patient education: a review of the literature. Lewis, D.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06134180?cond=%22Financial%20Stress%22&viewType=Table&rank=8

Study Details | NCT06134180 | CONFIDENCE-AI Financial ... Stress, Psychological. Behavioral Symptoms. Behavior. Alzheimer Disease. Dementia. Caregiver Burden. Financial Stress. Plan for Individual Participant Data (IPD).

2. withpower.com withpower.com/trial/phase-alzheimer-disease-2024-77bcf

Financial Education for Caregiver Burden (CONFIDENCE ... These findings suggest that financial education for caregivers, like CONFIDENCE-AI, may help improve caregiver confidence and reduce their burden.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05292248

CONFIDENCE Financial Education for Caregivers See Delay Results Type in the Results Data Element definitions for ... Caregiver BurdenFinancial StressDementiaAlzheimer Disease. Caregiver ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978356/

Protocol for a systematic review and meta-analysis - PMC This systematic review will evaluate the effectiveness of fully automated, AI-driven chatbot interventions for reducing subjective burden among ...

5. formative.jmir.org formative.jmir.org/2025/1/e70471

Acceptability of a Web-Based Financial Education Intervention ... Cultural norms, limited access to financial resources, and underrepresentation in intervention research compound this economic burden. There ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003696/

Lessons from a Pilot Study of a Culturally Tailored ... No difference was found in financial burden between the intervention and control groups. Most promising is a recent study that considered the efficacy of a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2950307825000785

Prevalence of depression, anxiety, burden, burnout, and ... Beyond the mental health consequences, caregivers frequently report substantial burden related to their caregiving duties, with longitudinal data suggesting ...