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Completed

NCT Number: NCT05599100

Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)

Behavioral

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 outcomes

  1. Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks (Overall Caregiver Reaction)

    Time frame: Change from baseline to 6 weeks

    The Revised Memory and Behavior Problem Checklist is a 24-item scale measuring caregiver reaction to memory, depression, and disruptive behavior problems. Each item asks about a problem the care recipient is experiencing. For each problem the care recipient experiences, caregivers are asked to rate how much the problem upsets the caregiver on a Likert scale ranging from 0 (not at all) to 4 (extremely). Scores for caregiver reaction are calculated by taking the sum of the individual items. Total scores can range from 0 to 96, with higher scores reflect caregivers being more upset when memory and behavior problems happen.

    We report the change in scores by subtracting the total score at baseline from the total score at 6 weeks. The possible range for the change in total scores is from -96 to 96. A negative change indicates that caregivers' reaction has improved, while a positive change indicates that caregivers' reaction has worsened.

  2. Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks

    Time frame: Change from baseline to 6 weeks

    In the Preparedness for Caregiving Scale, caregivers 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 4 (very well prepared). The score is calculated by taking the average of all items answered.

    We report the change in average scores by subtracting the average score at baseline from the average score at 6 weeks. The possible range for the change in average scores is from -4 to 4. A negative change indicates that caregivers' preparedness has worsened, while a positive change indicates that caregivers' preparedness has improved.

Secondary outcomes

  1. System Usability Scale

    Time frame: Week 1

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

  2. System Usability Scale

    Time frame: Week 2

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

  3. System Usability Scale

    Time frame: Week 3

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

  4. System Usability Scale

    Time frame: Week 4

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

  5. System Usability Scale

    Time frame: Week 5

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

  6. System Usability Scale

    Time frame: Week 6

    The System Usability Scale (SUS) is a 10-item questionnaire designed to assess the usability of and caregivers' satisfaction with the modules. Caregivers rate their agreement with statements on a 5-point scale, from "strongly disagree" to "strongly agree." A single score is calculated by converting each item's score to a 0-4 scale, summing the adjusted scores, and then multiplying by 2.5 to obtain a final score ranging from 0 to 100. Higher scores indicate better usability and caregiver satisfaction. General interpretive ranges suggest excellent usability (score of 85 and above), good usability (scores of 70-84), average usability (scores of 50-69), and poor usability (scores below 50).

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kaiser Permanente
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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