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

Sponsor
Case Western Reserve University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06134180
Collaborator
(none)
42
1
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CONFIDENCE-AI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An AI-Embedded Intervention to Promote Financial Wellbeing Among Latino Family Caregivers
Anticipated Study Start Date :
Jan 7, 2024
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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).]

    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).

  2. Resourcefulness [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; 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

Secondary Outcome Measures

  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).]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Case Western Reserve University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kylie Meyer, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT06134180
Other Study ID Numbers:
  • STUDY20230876
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023