Trial Outcomes & Findings for CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI) (NCT NCT06134180)

Last Updated: 2025-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

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).

Results posted on

2025-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	14
Overall Study Completed Baseline	14
Overall Study Completed First Follow up Survey	11
Overall Study Completed Second Follow up Survey	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	4

Baseline Characteristics

One participant skipped a survey item at baseline required to calculate financial strain score.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CONFIDENCE AI n=14 Participants 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
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=14 Participants
Age, Categorical >=65 years	1 Participants n=14 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 7.1 • n=14 Participants
Sex: Female, Male Female	10 Participants n=14 Participants
Sex: Female, Male Male	4 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	1 Participants n=14 Participants
Race (NIH/OMB) White	6 Participants n=14 Participants
Race (NIH/OMB) More than one race	2 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=14 Participants
Region of Enrollment United States	14 participants n=14 Participants
Financial Strain	28.4 units on a scale STANDARD_DEVIATION 5.6 • n=13 Participants • One participant skipped a survey item at baseline required to calculate financial strain score.
Resourcefulness	75.3 units on a scale STANDARD_DEVIATION 34.1 • n=13 Participants • One caregiver skipped a survey item required to calculate a score on this measure at baseline.
Self-Efficacy	32.0 units on a scale STANDARD_DEVIATION 16.7 • n=14 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CONFIDENCE AI n=10 Participants 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
Financial Strain Change score from baseline scores until post-intervention	-3.4 units on a scale Standard Deviation 4.9
Financial Strain Change score from baseline scores until 2-months post-intervention	-4.7 units on a scale Standard Deviation 6.6

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	CONFIDENCE AI n=14 Participants 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
Resourcefulness Change score from baseline scores until post-intervention	13.2 score on a scale Standard Deviation 25.7
Resourcefulness Change score from baseline scores until 2-months post-intervention	11.3 score on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	CONFIDENCE AI n=14 Participants 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
Self-Efficacy Change score from baseline scores until post-intervention	16.3 units on a scale Standard Deviation 15.2
Self-Efficacy Change score from baseline scores until 2-months post-intervention	13.2 units on a scale Standard Deviation 10.3

Adverse Events

CONFIDENCE-AI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kylie Meyer

Case Western Reserve Unviersity

Phone: 2163681928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place