Alzheimer DiseaseCONFIDENCE-AINCT06134180

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

A study testing CONFIDENCE-AI in people with Alzheimer Disease and Dementia, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease, Dementia, Caregiver Burden
What is being tested?: CONFIDENCE-AI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2024to 19 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Western Reserve University
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

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.

Conditions: Alzheimer Disease, Dementia, Caregiver Burden, Financial Stress
Being tested: CONFIDENCE-AI
Medical subject headings: Alzheimer Disease, Dementia, Caregiver Burden, Financial Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CONFIDENCE-AIBehavioural
Multicomponent psychoeducational intervention focused on financial wellbeing

Study groups in NCT06134180
Study group	Role	What they receive
CONFIDENCE AI	Experimental	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. Receives: Behavioral: CONFIDENCE-AI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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
Measured: 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).

Secondary outcomes (1)

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).
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202419 May 2025

First posted18 Nov 2023
Study start23 Mar 2024
Primary completion1 Apr 2025
Study completion19 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06134180
Sponsor's protocol ID: STUDY20230876
Acronym: CONFIDENCE-AI
Status last verified: Jul 2025
First submitted: 6 Nov 2023
Last updated: 30 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified survey data, such as pre- and post-test data, will be stored and available upon reasonable request with qualified investigators following the appropriate establishment of a data use agreement.

Publications

Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.
PubMed 16764178
Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.
PubMed 33146727
Sadigh G, Switchenko J, Weaver KE, Elchoufi D, Meisel J, Bilen MA, Lawson D, Cella D, El-Rayes B, Carlos R. Correlates of financial toxicity in adult cancer patients and their informal caregivers. Support Care Cancer. 2022 Jan;30(1):217-225. doi: 10.1007/s00520-021-06424-1. Epub 2021 Jul 13.
PubMed 34255179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease

All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An AI-Embedded Intervention to Promote Financial Wellbeing Among Latino Family Caregivers
ClinicalTrials.gov ID: NCT06134180
Acronym / sponsor ID: CONFIDENCE-AI / STUDY20230876
Conditions: Alzheimer Disease, Dementia, Caregiver Burden, Financial Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 23 Mar 2024 (actual)
Primary completion: 1 Apr 2025 (actual)
Study completion: 19 May 2025 (actual)
First posted: 18 Nov 2023 (actual)
Results: Posted 30 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CONFIDENCE AI	Experimental	Behavioral: CONFIDENCE-AIParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CONFIDENCE-AIMulticomponent psychoeducational intervention focused on financial wellbeing	Behavioural	CONFIDENCE AI

Primary outcome

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.
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

1 secondary outcome

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).

Results and safety

Results posted to the registry on 30 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CONFIDENCE AI	14	10

Primary outcome: 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).. Mean (Standard Deviation). Unit: units on a scale

Measure	CONFIDENCE AI n = 10
Change score from baseline scores until post-intervention	-3.4 (4.9)
Change score from baseline scores until 2-months post-intervention	-4.7 (6.6)

Population analysed: 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.

Primary outcome: Resourcefulness

Measure	CONFIDENCE AI n = 14
Change score from baseline scores until post-intervention	13.2 (25.7)
Change score from baseline scores until 2-months post-intervention	11.3 (13.3)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through study completion, approximately 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CONFIDENCE-AI	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16764178Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.
Background: PubMed 33146727Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.
Background: PubMed 34255179Sadigh G, Switchenko J, Weaver KE, Elchoufi D, Meisel J, Bilen MA, Lawson D, Cella D, El-Rayes B, Carlos R. Correlates of financial toxicity in adult cancer patients and their informal caregivers. Support Care Cancer. 2022 Jan;30(1):217-225. doi: 10.1007/s00520-021-06424-1. Epub 2021 Jul 13.
Individual participant dataSharing planned: Yes. De-identified survey data, such as pre- and post-test data, will be stored and available upon reasonable request with qualified investigators following the appropriate establishment of a data use agreement.

Related trials for Alzheimer Disease

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kylie Meyer, PhD principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CONFIDENCE-AI in people with Alzheimer Disease and Dementia, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134180, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.