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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease; Caregiver Burden; Financial Stress
• Intervention / Treatment: Behavioral: CONFIDENCE-AI

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kylie Meyer, PhD; Phone Number: 2163681928; Email: knm77@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Contact: Kylie Meyer, PhD; Email: knm77@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CONFIDENCE AI; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (α=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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Kylie Meyer, PhD, Case Western Reserve University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; Dementia; Tauopathies; Alzheimer Disease; Caregiver Burden; Financial Stress
• Other Study ID Numbers: STUDY20230876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified survey data, such as pre- and post-test data, will be stored and available upon reasonable request with qualified investigators following the appropriate establishment of a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No