CONFIDENCE Financial Education for Caregivers (CONFIDENCE)

January 8, 2024 updated by: Kylie Meyer, Case Western Reserve University

Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kylie Meyer, PhD
  • Phone Number: 216-368-1928
  • Email: knm77@case.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Caregiver to someone diagnosed by a physician with probably Alzheimer's disease or a related dementia at least 6 months ago
  • Latino or Hispanic ethnicity
  • At least 50 years of age of older
  • Able to attend 5, 1.5 hour to 2 hour group-based lessons over 5 weeks
  • No plans to place family member in a facility within the next 3 months

Exclusion Criteria:

  • Unreliable access to email, a computer and internet access
  • Does note speak and read English
  • Previously participated in CONFIDENCE program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CONFIDENCE Education Intervention
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.
Behavioral: Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Multicomponent psychoeducational intervention focused on financial wellbeing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly out-of-pocket caregiving costs
Time Frame: Change 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 (Rainville et al., 2016). 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.
Change from baseline to 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological financial strain
Time Frame: 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 11 ask about financial anxiety and is based on the 10-item scale from Shapiro & Burchell (2012). The investigators added an item based on another related to caregiving (i.e., "I find planning for my caregiving expenses to be unpleasant"). Items 12 to 14 are based on those used by Novilitis et al., (2003), and address additional components of financial anxiety than those items introduced by Shapiro (e.g., arguments with others; alpha=0.74). Lastly, the investigators included the 1-item question from Shim et al. (2010) that asks about financial worry ("I worry constantly about money"; CFA factor loading was 0.79 for this item). 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 (within 1 week); change from baseline to 8 weeks post-intervention
Caregiver self-efficacy
Time Frame: 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 (Ritter et al., In Press). 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.
Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
Caregiver resourcefulness
Time Frame: 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; Zauszniewski, 2006). 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
Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

University of Southern California
AARP Foundation

Investigators

  • Principal Investigator: Kylie Meyer, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210794HU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be made available to qualified investigators upon request to the PI.

IPD Sharing Time Frame

Data will be made available, upon request, within 1 year of the study close date or the first publication using research data described, whichever comes first.

IPD Sharing Access Criteria

Access will be provided using .csv files for de-identified study data and PDF supporting documents, sent by email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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