CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI)

Alzheimer Disease Clinical Trial

— CONFIDENCE-AI  

Official title:

An AI-Embedded Intervention to Promote Financial Wellbeing Among Latino Family Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134180
• Other study ID #: STUDY20230876
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Case Western Reserve University
• Contact: Kylie Meyer, PhD
• Phone: 2163681928
• Email: knm77[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified caregiver to a person diagnosed by a physician with Alzheimer's disease or related dementia at least 6 months ago
• Latino/Hispanic ethnicity.

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
• Does not agree to participate in at least 3 of the 4 group sessions and/or register for the NeuViCare app
• Unable to read and speak in English or Spanish

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden
• Dementia
• Financial Stress

Intervention

Behavioral:
• CONFIDENCE-AI
Multicomponent psychoeducational intervention focused on financial wellbeing

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174. — View Citation

Sadigh G, Switchenko J, Weaver KE, Elchoufi D, Meisel J, Bilen MA, Lawson D, Cella D, El-Rayes B, Carlos R. Correlates of financial toxicity in adult cancer patients and their informal caregivers. Support Care Cancer. 2022 Jan;30(1):217-225. doi: 10.1007/s00520-021-06424-1. Epub 2021 Jul 13. — View Citation

Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Financial Strain	Financial strain will be measured using the 11-item Comprehensive Score for Financial Toxicity (COST) Scale. A modified version of COST demonstrates validity and reliability when tested among cancer caregivers (a=0.91; range: 0 to 44). COST items are generic enough to be applicable to caregivers to persons PLWD without further modification (e.g., "I feel financially stressed"). Caregivers are asked to indicate if each statement applies to them "Not at all" (0) to "Very much" (4).	The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).
Primary	Resourcefulness	Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (alpha=0.85; Zauszniewski, 2006). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores	The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).
Secondary	Self-Efficacy	Self-efficacy is measured using the Caregiver Self-Efficacy Scale (Ritter et al., In Press). This 8-item scale asks about multiples domains of self-efficacy (e.g., managing behavioral symptoms, accessing respite, and controlling upsetting thoughts). It demonstrates high reliability (alpha=0.89) and good test-retest reliability (0.73). Participants rate the extent to which they are "Not confident at all" (1) to "Totally confident" (10). Scores range from 8 (lowest level of self-efficacy) to 80 (highest level of self-efficacy).	The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline).