Trial Outcomes & Findings for CONFIDENCE Financial Education for Caregivers (NCT NCT05292248)

Last Updated: 2024-08-23

Results Overview

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-reports of spending will be averaged and multiplied by 6 to approximate the number of days in a month, and added to estimated monthly costs. Positive scores indicate increased out-of-pocket costs. The researchers advise against relying on this outcome. In this pilot study, we found that this measure has qualitatively different meanings for adult child and spousal caregivers.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Change in median costs from from baseline to 8 weeks post-intervention

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	CONFIDENCE Education Intervention Participants attended the 5-week CONFIDENCEProgram. This program involved attending 5 group-based sessions delivered by videoconference. Each session lasted approximately 1.5 hours each and covered topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Overall Study STARTED	20
Overall Study Completed Intervention	18
Overall Study Follow Up Survey	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number of participants with baseline data on out-of-pocket costs of care is lower than those who completed the baseline survey because 4 participants who completed the baseline survey did not complete the daily spending surveys.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CONFIDENCE Education Intervention n=20 Participants Participants will attend the 5-week CONFIDENCEProgram. This program will include attending 5 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, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Age, Continuous	58.6 years STANDARD_DEVIATION 6.3 • n=20 Participants
Sex: Female, Male Female	17 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants
Race (NIH/OMB) White	12 Participants n=20 Participants
Race (NIH/OMB) More than one race	1 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants
Monthly out-of-pocket caregiving costs	3755 Dollars n=16 Participants • The number of participants with baseline data on out-of-pocket costs of care is lower than those who completed the baseline survey because 4 participants who completed the baseline survey did not complete the daily spending surveys.
Psychological financial strain	17.9 units on a scale STANDARD_DEVIATION 11.0 • n=20 Participants
Caregiver Self-Efficacy	40.6 units on a scale STANDARD_DEVIATION 13.5 • n=19 Participants • One participant had missing data on this measure.
Resourcefulness	82.7 units on a scale STANDARD_DEVIATION 26.0 • n=16 Participants • Four participants had missing data on this measure.

PRIMARY outcome

Timeframe: Change in median costs from from baseline to 8 weeks post-intervention

Population: Although all 20 participants were asked to complete daily spending surveys used to calculuate monthly out-of-pocket caregiving costs, only 16 completed daily spendin surveys at baseline. Of these participants, 10 completed daily spending surveys at the 2-month follow-up time. However, one follow-up survey was removed from analyses since it was an extreme outlier (i.e., 16 times higher than next highest monthly cost calculated).

Outcome measures

Outcome measures
Measure	CONFIDENCE Education Intervention n=9 Participants Participants attended the 5-week CONFIDENCEProgram. This program involved attending 5 group-based sessions delivered by videoconference. Each session lasted approximately 1.5 hours each and covered topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Monthly Out-of-pocket Caregiving Costs	480 Dollars Interval 149.0 to 994.0

SECONDARY outcome

Timeframe: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Population: In both the first follow up and second follow up survey, there were 6 missing cases. In addition, for item-level missingness on this scale contributes to missing data for 2 additional cases.

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.

Outcome measures

Outcome measures
Measure	CONFIDENCE Education Intervention n=14 Participants Participants attended the 5-week CONFIDENCEProgram. This program involved attending 5 group-based sessions delivered by videoconference. Each session lasted approximately 1.5 hours each and covered topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Psychological Financial Strain Change from baseline to 8 weeks post-intervention	-4.3 score on a scale Standard Deviation 5.1
Psychological Financial Strain Change from baseline to post-intervention	-4.6 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Population: A participant had item-level missingness at baseline, such that baseline data is available for 19 participants. Six participants did not complete the first follow up and the second follow up survey. Another participant had missing item-level data in the first follow up survey, such that there are 7 missing cases for "Change from baseline to post-intervention" and 6 missing cases for "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 indicate an increase in self-efficacy.

Outcome measures

Outcome measures
Measure	CONFIDENCE Education Intervention n=19 Participants Participants attended the 5-week CONFIDENCEProgram. This program involved attending 5 group-based sessions delivered by videoconference. Each session lasted approximately 1.5 hours each and covered topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Caregiver Self-efficacy Change from baseline to post-intervention	15.2 score on a scale Standard Deviation 8.5
Caregiver Self-efficacy Change from baseline to 8 weeks post-intervention	15.6 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Population: Six participants did not complete the first follow up and the second follow up survey. In addition, two other participants had missing item-level data in the first follow up survey and another 4 had missing item-level data on the second follow up survey, such that there are 8 missing cases for "Change from baseline to post-intervention" and 10 missing cases for "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. The outcome measure will use the average change score from baseline scores

Outcome measures

Outcome measures
Measure	CONFIDENCE Education Intervention n=16 Participants Participants attended the 5-week CONFIDENCEProgram. This program involved attending 5 group-based sessions delivered by videoconference. Each session lasted approximately 1.5 hours each and covered topics such as how to budget, accessing community resources to displace the out-of-pocket costs of caregiving, asking for help, balancing employment and caregiving, and more. Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving: Multicomponent psychoeducational intervention focused on financial wellbeing
Caregiver Resourcefulness Change from baseline to post-intervention	12.8 score on a scale Standard Deviation 10.6
Caregiver Resourcefulness Change from baseline to 8 weeks post-intervention	9.2 score on a scale Standard Deviation 9.7

Adverse Events

CONFIDENCE Education Intervention

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, Principal Investigator

Case Western Reserve University

Phone: 216-368-1928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place