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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05292248
Other study ID # 20210794HU
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date March 1, 2024

Study information

Verified date January 2024
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date March 1, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Confidently Navigating Financial Decisions and Enhancing Financial Wellbeing in Dementia Caregiving
Multicomponent psychoeducational intervention focused on financial wellbeing

Locations

Country Name City State
United States Case Western Reserve University Cleveland Ohio

Sponsors (3)

Lead Sponsor Collaborator
Case Western Reserve University AARP Foundation, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (6)

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.

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

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. — View Citation

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

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline to 8 weeks post-intervention
Secondary 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. Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
Secondary 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. Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
Secondary 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 Change from baseline to post-intervention (within 1 week); change from baseline to 8 weeks post-intervention
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