NCT06134180: CONFIDENCE-AI

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

Completed NA Results posted Last updated 30 July 2025

What this trial tests

NA trial testing CONFIDENCE-AI in Alzheimer Disease in 14 participants. Completed in 19 May 2025.

Timeline

23 March 2024

Primary endpoint
1 April 2025

19 May 2025

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	14
Start date	23 March 2024
Primary completion	1 April 2025
Estimated completion	19 May 2025
Sites	1 location across United States

Drugs / interventions tested

• CONFIDENCE-AI

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia — all drugs for Dementia →
• Caregiver Burden — all drugs for Caregiver Burden →
• Financial Stress — all drugs for Financial Stress →

Sponsor

Case Western Reserve University

Who can join

18 and older, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Financial Strain Primary · 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.

Change score from baseline scores until post-intervention

Group	Value	95% CI
CONFIDENCE AI	-3.4	± 4.9

Change score from baseline scores until 2-months post-intervention

Group	Value	95% CI
CONFIDENCE AI	-4.7	± 6.6

Resourcefulness Primary · 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. Th

Change score from baseline scores until post-intervention

Group	Value	95% CI
CONFIDENCE AI	13.2	± 25.7

Change score from baseline scores until 2-months post-intervention

Group	Value	95% CI
CONFIDENCE AI	11.3	± 13.3

Self-Efficacy Secondary · 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).

Change score from baseline scores until post-intervention

Group	Value	95% CI
CONFIDENCE AI	16.3	± 15.2

Change score from baseline scores until 2-months post-intervention

Group	Value	95% CI
CONFIDENCE AI	13.2	± 10.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.