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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06134180
Acronym
CONFIDENCE-AI
Enrollment
14
Registered
2023-11-18
Start date
2024-03-23
Completion date
2025-05-19
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Caregiver Burden, Dementia, Financial Stress

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.

Interventions

BEHAVIORALCONFIDENCE-AI

Multicomponent psychoeducational intervention focused on financial wellbeing

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Financial StrainThe 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.
ResourcefulnessThe 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

MeasureTime frameDescription
Self-EfficacyThe 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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. CONFIDENCE-AI: Multicomponent psychoeducational intervention focused on financial wellbeing
14
Total14

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up4

Baseline characteristics

CharacteristicCONFIDENCE AI
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
Age, Continuous54.3 years
STANDARD_DEVIATION 7.1
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Financial Strain28.4 units on a scale
STANDARD_DEVIATION 5.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
14 participants
Resourcefulness75.3 units on a scale
STANDARD_DEVIATION 34.1
Self-Efficacy32.0 units on a scale
STANDARD_DEVIATION 16.7
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 14
other
Total, other adverse events
0 / 14
serious
Total, serious adverse events
0 / 14

Outcome results

Primary

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.

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).

Population: From baseline to the post-intervention data collection point, three participants were lost to follow up and one participant was missing a survey item response required to calculate this score. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and another was missing a survey item response required to calculate this score. Thus, data is available for 9 of 14 participants.

ArmMeasureGroupValue (MEAN)Dispersion
CONFIDENCE AIFinancial StrainChange score from baseline scores until post-intervention-3.4 units on a scaleStandard Deviation 4.9
CONFIDENCE AIFinancial StrainChange score from baseline scores until 2-months post-intervention-4.7 units on a scaleStandard Deviation 6.6
Primary

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

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).

Population: From baseline to the post-intervention data collection point, three participants were lost to follow up and one participant was missing a survey item response required to calculate this score. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and two more cases were missing a survey item response required to calculate this score. Thus, data is available for 8 of 14 participants.

ArmMeasureGroupValue (MEAN)Dispersion
CONFIDENCE AIResourcefulnessChange score from baseline scores until post-intervention13.2 score on a scaleStandard Deviation 25.7
CONFIDENCE AIResourcefulnessChange score from baseline scores until 2-months post-intervention11.3 score on a scaleStandard Deviation 13.3
Secondary

Self-Efficacy

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).

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).

Population: From baseline to the post-intervention data collection point, three participants were lost to follow up. Thus, data is available for 10 of 14 participants.~From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and another was missing a survey item response required to calculate this score. Thus, data is available for 9 of 14 participants.

ArmMeasureGroupValue (MEAN)Dispersion
CONFIDENCE AISelf-EfficacyChange score from baseline scores until post-intervention16.3 units on a scaleStandard Deviation 15.2
CONFIDENCE AISelf-EfficacyChange score from baseline scores until 2-months post-intervention13.2 units on a scaleStandard Deviation 10.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026