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OpenTrials
Completed

NCT Number: NCT06134180

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

CONFIDENCE-AI

Behavioral

Multicomponent psychoeducational intervention focused on financial wellbeing

Primary outcomes

  1. Financial Strain

    Time frame: 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).

    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.

  2. Resourcefulness

    Time frame: 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 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

Secondary outcomes

  1. Self-Efficacy

    Time frame: 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).

    Self-efficacy is measured using the Caregiver Self-Efficacy Scale. This 8-item scale asks about multiple 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).

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Acronym: CONFIDENCE-AI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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