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

NCT06134180 | Completed Results

• 1 other identifier: STUDY20230876
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Caregiver Burden; Financial Stress

Outcome Measures

Primary Outcomes (2)

• 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). Higher scores indicate higher levels of financial strain.

  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). 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 Outcomes (1)

• 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).

Study Arms (1)

CONFIDENCE AI

EXPERIMENTAL

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

Interventions

CONFIDENCE-AI BEHAVIORAL

Multicomponent psychoeducational intervention focused on financial wellbeing

CONFIDENCE AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified caregiver to a person living with probable Alzheimer's disease or related dementia
• Person living with dementia meets stage 4 to 6 criteria on Global Deterioration Scale according to the family caregiver
• Has been at least 6 months since the care recipient began to experience dementia symptoms
• Latino/Hispanic ethnicity.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

• 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.

  PMID: 16764178 BACKGROUND

• 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.

  PMID: 33146727 BACKGROUND

• 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.

  PMID: 34255179 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Caregiver Burden; Financial Stress

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Kylie Meyer
• Organization: Case Western Reserve Unviersity

knm77@case.edu

2163681928

Study Officials

• Kylie Meyer, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: March 23, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 19, 2025
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Information will be available upon study completion (i.e., once primary studies are published). De-identified data will be stored for at least 3 years following study completion.

Locations

US (1)