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

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The intervention being tested, CONFIDENCE-AI is a refined version of the original CONFIDENCE intervention made to reduce psychological financial strain and improve management of out-of-pocket care costs while increasing caregiver resourcefulness skills. Participants will be asked to participate in a 4-week intervention that includes participation in four, synchronous group-based Zoom sessions as well as between-session activities to apply learning. Participants will also receive tailored text message notifications from the NeuViCare AI-powered app via text and will be able to submit questions to the app to receive financial well-being information related to caregiving.

Will I have to stop taking my current medications?

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

How is the treatment CONFIDENCE-AI Financial Education for Caregivers different from other treatments for caregiver burden?

CONFIDENCE-AI is unique because it focuses on financial education to help reduce caregiver burden, unlike other treatments that may focus on general education or internet-based support. This approach aims to address the financial stress caregivers often face, which is not typically the primary focus of other interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CONFIDENCE-AI Financial Education for Caregivers?

Research shows that digital and computer-based patient education can improve knowledge and clinical outcomes, and self-management education can enhance confidence and reduce costs in chronic disease management. These findings suggest that financial education for caregivers, like CONFIDENCE-AI, may help improve caregiver confidence and reduce their burden. ^{6 7 8 9 10}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Review of Digitalized Patient Education in Cardiology: A Future Ahead? [2021]

2. England pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

How to improve patient education. [2007]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Patient self-management of chronic disease in primary care. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Supportive Interventions for Family Caregivers of People With Dementia: Systematic Review and Meta-Analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cancer Caregiver: Perceived Benefits of Technology. [2018]

8. England pubmed.ncbi.nlm.nih.gov

EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Supportive care needs of Americans: a major issue for women as both recipients and providers. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

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