CONFIDENCE Financial Education for Caregivers (CONFIDENCE)
Primary Purpose
Caregiver Burden, Financial Stress, Dementia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Sponsored by
About this trial
This is an interventional treatment trial for Caregiver Burden focused on measuring Out-of-pocket costs, Behavioral intervention, Hispanic, Latino, Self-Efficacy
Eligibility Criteria
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
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CONFIDENCE Education Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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 (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.
Secondary Outcome Measures
Psychological financial strain
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.
Caregiver self-efficacy
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.
Caregiver resourcefulness
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
Full Information
NCT ID
NCT05292248
First Posted
March 14, 2022
Last Updated
October 12, 2023
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT05292248
Brief Title
CONFIDENCE Financial Education for Caregivers
Acronym
CONFIDENCE
Official Title
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Financial Stress, Dementia, Alzheimer Disease
Keywords
Out-of-pocket costs, Behavioral intervention, Hispanic, Latino, Self-Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONFIDENCE Education Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Intervention Description
Multicomponent psychoeducational intervention focused on financial wellbeing
Primary Outcome Measure Information:
Title
Monthly out-of-pocket caregiving costs
Description
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.
Time Frame
Change from baseline to 8 weeks post-intervention
Secondary Outcome Measure Information:
Title
Psychological financial strain
Description
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.
Time Frame
Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
Title
Caregiver self-efficacy
Description
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.
Time Frame
Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
Title
Caregiver resourcefulness
Description
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
Time Frame
Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kylie Meyer, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
33146727
Citation
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.
Results Reference
background
PubMed Identifier
20938727
Citation
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.
Results Reference
background
Citation
Shapiro GK, Burchell BJ. Measuring financial anxiety. Journal of Neuroscience, Psychology, and Economics. 2012;5(2):92-103.
Results Reference
background
PubMed Identifier
16764178
Citation
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.
Results Reference
background
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CONFIDENCE Financial Education for Caregivers
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