Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Study Overview
=================
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.

Official Title
-----------------
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

Conditions
-----------------
Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms

Intervention / Treatment
-----------------
* Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAR-VTF<br>Participants will receive the STAR-VTF intervention. | Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |