NCT05292248: CONFIDENCE

CONFIDENCE Financial Education for Caregivers

Completed NA Results posted Last updated 23 August 2024

What this trial tests

NA trial testing Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving in Caregiver Burden in 20 participants. Completed in 1 March 2024.

Timeline

1 May 2022

Primary endpoint
15 December 2023

1 March 2024

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2022
Primary completion	15 December 2023
Estimated completion	1 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving

Conditions studied

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

Sponsor

Case Western Reserve University

Who can join

50 and older, any sex, with Caregiver Burden or Financial Stress. 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.

Monthly Out-of-pocket Caregiving Costs Primary · Change in median costs from from baseline to 8 weeks post-intervention

Monthly out-of-pocket costs of caregiving is based on the tool used by the AARP Public Policy Institute in their 2016 report on the out-of-pocket costs of caregiving. This measure combines caregiver recall of care costs in the previous month, collected at baseline, with 5 days of daily spending diaries. Daily surveys will be sent using an email with a survey link, and a text message reminder. Monthly costs include less-frequent, high-cost expenditures (e.g., mortgage payment), while daily costs include lower-cost items caregivers may pay for more frequently (e.g., groceries). Daily self-report

Group	Value	95% CI
CONFIDENCE Education Intervention	480	149 – 994

Psychological Financial Strain Secondary · Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

The measure for psychological financial strain is from multiple scales. Items 1 to 14 ask about financial anxiety. Lastly, the investigators included the 1-item question that asks about financial worry ("I worry constantly about money". Participants are asked to indicate the extent to which each statement is true (Very true \[3\], Somewhat true\[2\], Somewhat untrue\[1\], and Complete untrue\[0\]). Scores are summed such that scores range from 0 to 45, where higher scores indicate higher levels of financial strain.

Change from baseline to post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	-4.6	± 7.8

Change from baseline to 8 weeks post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	-4.3	± 5.1

Caregiver Self-efficacy Secondary · Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Self-efficacy is measured using the Caregiver Self-Efficacy Scale. 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). The outcome measure will use the average change score from baseline scores. Positive scores in

Change from baseline to post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	15.2	± 8.5

Change from baseline to 8 weeks post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	15.6	± 6.5

Caregiver Resourcefulness Secondary · Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

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 from baseline to post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	12.8	± 10.6

Change from baseline to 8 weeks post-intervention

Group	Value	95% CI
CONFIDENCE Education Intervention	9.2	± 9.7

Sponsor's own description

The purpose of this study is to determine how feasible it is to deliver an online course to reduce out-of-pocket costs of caregiving and reduce financial stress among Latino family caregivers to a family member living with dementia. The investigators hope that that the results of this study will help to reduce high these out-of-pocket costs and improve financial wellbeing for Latino family caregivers.

Caregivers will be asked to to participate in 3 online surveys, in addition to participating in 5, 1.5 hour group-based Zoom learning sessions.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lessons from a Pilot Study of a Culturally Tailored Financial Well-Being Intervention Among Latino Family Caregivers.
   Meyer K, Mage SM, Gonzalez A, Zauszniewski JA, et al · · 2025 · cited 2× · PMID 39420566 · DOI 10.1177/07334648241293524
2. WE BUILT IT, BUT THEY DIDN’T COME: CHALLENGES WITH RECRUITMENT AND RETENTION IN THE CONFIDENCE PILOT STUDY
   · 2023
3. A BIOPSYCHOSOCIAL APPROACH TOWARD PREDICTING PHYSICAL ACTIVITY AMONG OLDER ADULTS WITH KNEE OSTEOARTHRITIS
   · 2023
4. ACCEPTABILITY OF THE CONFIDENCE INTERVENTION: INITIAL RESULTS FROM SATISFACTION SURVEYS AND QUALITATIVE INTERVIEWS
   · 2023
5. PRELIMINARY RESULTS OF THE CONFIDENCE FINANCIAL INTERVENTION FOR CAREGIVERS TO PERSONS LIVING WITH DEMENTIA
   · 2023