NCT05292248

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 23, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

March 14, 2022

Results QC Date

January 14, 2024

Last Update Submit

August 22, 2024

Conditions

Keywords

Out-of-pocket costsBehavioral interventionHispanicLatinoSelf-Efficacy

Outcome Measures

Primary Outcomes (1)

  • Monthly Out-of-pocket Caregiving Costs

    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.

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

Secondary Outcomes (3)

  • Psychological Financial Strain

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

  • Caregiver Self-efficacy

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

  • Caregiver Resourcefulness

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

Study Arms (1)

CONFIDENCE Education Intervention

EXPERIMENTAL

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

Interventions

Multicomponent psychoeducational intervention focused on financial wellbeing

CONFIDENCE Education Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (7)

  • Rainville C, Skufca L, Mehegan L. Family Caregiving and Out-of-Pocket Costs: 2016 Report: AARP; 2016. https://www.khi.org/assets/uploads/news/14680/family-caregiving-cost-survey-res-ltc.pdf

    BACKGROUND
  • Norvilitis JM, Szablicki PB, Wilson SD. Factors Influencing Levels of Credit-Card Debt in College Students. J of Applied Social Psychology 2003;33(5):935-47.

    BACKGROUND
  • 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.

    PMID: 33146727BACKGROUND
  • Shim S, Barber BL, Card NA, Xiao JJ, Serido J. Financial socialization of first-year college students: the roles of parents, work, and education. J Youth Adolesc. 2010 Dec;39(12):1457-70. doi: 10.1007/s10964-009-9432-x. Epub 2009 Jul 4.

    PMID: 20938727BACKGROUND
  • Shapiro GK, Burchell BJ. Measuring financial anxiety. Journal of Neuroscience, Psychology, and Economics. 2012;5(2):92-103.

    BACKGROUND
  • 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.

    PMID: 16764178BACKGROUND
  • Meyer K, Mage SM, Gonzalez A, Zauszniewski JA, Rhodes S, Perales-Puchalt J, Wilber K, Song L, Puga F, Benton D. Lessons from a Pilot Study of a Culturally Tailored Financial Well-Being Intervention Among Latino Family Caregivers. J Appl Gerontol. 2025 Jun;44(6):938-948. doi: 10.1177/07334648241293524. Epub 2024 Oct 17.

MeSH Terms

Conditions

Caregiver BurdenFinancial StressDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Kylie Meyer, Principal Investigator
Organization
Case Western Reserve University

Study Officials

  • Kylie Meyer, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

May 1, 2022

Primary Completion

December 15, 2023

Study Completion

March 1, 2024

Last Updated

August 23, 2024

Results First Posted

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
Access Criteria
Access will be provided using .csv files for de-identified study data and PDF supporting documents, sent by email.

Locations