Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
Primary Purpose
Caregiver Burden, Alzheimer Disease, Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden
Eligibility Criteria
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
Sites / Locations
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STAR-VTF
Arm Description
Participants will receive the STAR-VTF intervention.
Outcomes
Primary Outcome Measures
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 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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT05599100
First Posted
October 23, 2022
Last Updated
September 8, 2023
Sponsor
University of Washington
Collaborators
Kaiser Permanente, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05599100
Brief Title
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
Official Title
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Kaiser Permanente, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STAR-VTF
Arm Type
Experimental
Arm Description
Participants will receive the STAR-VTF intervention.
Intervention Type
Behavioral
Intervention Name(s)
STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks
Description
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).
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
System Usability Scale
Description
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).
Time Frame
Week 1
Title
System Usability Scale
Description
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).
Time Frame
Week 2
Title
System Usability Scale
Description
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).
Time Frame
Week 3
Title
System Usability Scale
Description
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).
Time Frame
Week 4
Title
System Usability Scale
Description
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).
Time Frame
Week 5
Title
System Usability Scale
Description
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).
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magaly Ramirez, PhD, MS, MS
Phone
2065439773
Email
maggiera@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magaly Ramirez, PhD, MS, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magaly Ramirez, PhD, MS, MS
Phone
206-543-9773
Email
maggiera@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1466831
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.
Results Reference
background
PubMed Identifier
21294937
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.
Results Reference
background
PubMed Identifier
33340272
Citation
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.
Results Reference
background
PubMed Identifier
33325828
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.
Results Reference
background
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Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
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