Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Alzheimer Disease Clinical Trial

Official title:

Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599100
• Other study ID #: STUDY00013410
• Secondary ID: 5U54AG063546-04
• Status: Completed
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to improve the STAR-Caregivers Virtual Training & Follow-up (STAR-VTF) intervention for Latino caregivers of people living with dementia. The main objectives are to: (1) culturally adapt STAR-VTF online training modules, (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop an online survey to collect caregiver outcomes in a future study. Participants will receive the STAR-VTF intervention and asked to complete online surveys and participate in an exit interview to provide feedback on their experience.

Description:

The objectives of this study are to: (1) culturally and linguistically adapt the STAR-Caregivers Virtual Training & Follow-up (STAR-VTF) online training modules for Latino caregivers of people living with dementia (PLWD), (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop a REDCap survey to pragmatically collect caregiver outcomes in a future study.

The study will use a single-arm pilot trial design with Latino caregivers of PLWD. The investigators will assess self-reported outcomes at baseline and 6-8 weeks post-enrollment using a REDCap survey. Outcome measures will include the Revised Memory and Problem Behavior Checklist and Preparedness for Caregiving Scale. In addition, the investigators will assess caregivers' perceived usability of the online training modules and will conduct qualitative interviews 6-8 weeks post-enrollment. The interviews will assess caregiver satisfaction with and acceptability of the adapted online training modules.

The investigators expect to enroll up to 20 participants. The primary objective of this study is to pilot test the adapted online training modules. Therefore, it is not powered to detect an effect of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Lives with a person living with dementia (PLWD) or within 5 miles

• Provides at least 8 hours of care per week

• Self-identifies as Hispanic/Latino

• Caregiver self-report of PLWD having = 3 behavioral and/or psychological symptoms of dementia occurring = 3 in past week

Exclusion Criterion:

• PLWD lives in assisted living or skilled nursing facilities

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral Symptoms
• Caregiver Burden
• Dementia

Intervention

Behavioral:
• STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
For 6-8 weeks, caregivers will complete online training modules asynchronously. Caregivers will be instructed to complete one module per week. The content of the modules is as follows: Module 1 introduces caregivers to the behavioral treatment of dementia, realistic expectations, and effective communication; Module 2 covers the ABC (antecedents, behaviors, consequences) approach to problem-solving, including rationale and development of an ABC plan; Module 3 instructs caregivers to review the ABC plan and revise as needed; Module 4 covers pleasant events and managing negative thinking; Module 5 instructs caregivers to review the ABC plan, pleasant activities schedule, and to revise as needed; Module 6 covers coping with caregiving and maintaining gains. Each module takes about 45 minutes to complete. The modules use text, pictures, and illustrations with a voiceover presentation. Caregivers will receive the online training modules in their preferred language (English or Spanish).

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Kaiser Permanente, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Gutierrez-Baena B, Romero-Grimaldi C. Development and psychometric testing of the Spanish version of the Caregiver Preparedness Scale. Nurs Open. 2021 May;8(3):1183-1193. doi: 10.1002/nop2.732. Epub 2020 Dec 19. — View Citation

Salvia MG, Dawidowski A, Schapira M, Figar S, Soderlund ME, Seinhart D, Camera L, Teri L. Spanish Revised Memory and Behavior Problems Checklist Scale (SpRMBPC): trans-cultural adaptation and validation of the RMBPC questionnaire. Int Psychogeriatr. 2011 Sep;23(7):1160-6. doi: 10.1017/S1041610210002073. Epub 2011 Feb 4. — View Citation

Sevilla-Gonzalez MDR, Moreno Loaeza L, Lazaro-Carrera LS, Bourguet Ramirez B, Vazquez Rodriguez A, Peralta-Pedrero ML, Almeda-Valdes P. Spanish Version of the System Usability Scale for the Assessment of Electronic Tools: Development and Validation. JMIR Hum Factors. 2020 Dec 16;7(4):e21161. doi: 10.2196/21161. — View Citation

Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems in dementia: the revised memory and behavior problems checklist. Psychol Aging. 1992 Dec;7(4):622-31. doi: 10.1037//0882-7974.7.4.622. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks	Caregivers will rate memory, depression, and disruptive behavior problems in people living with dementia. The instrument contains 24 items (7 memory-related, 8 depressive, and 9 disruptive) that assess problem behaviors and are rated for frequency of occurrence during the past week and caregiver reaction to the problem behaviors.	Change from baseline to 6 weeks
Primary	Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks	Caregivers will rate how prepared they are for various aspects of caregiving. The instrument contains 8 items that ask caregivers how well prepared they believe they are to provide physical care, emotional support, deal with the stress of caregiving, and set up in-home support services. Each item is rated on a 5-point scale ranging from 0 (not at all prepared) to 5 (very well prepared).	Change from baseline to 6 weeks
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 1
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 2
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 3
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 4
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 5
Secondary	System Usability Scale	Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree).	Week 6