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.

Study Overview

• Status: Completed
• Conditions: Behavioral Symptoms; Dementia; Alzheimer Disease; Caregiver Burden
• Intervention / Treatment: Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: STAR-VTF; Participants will receive the STAR-VTF 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).

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 (Overall Caregiver Reaction)	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.	Change from baseline to 6 weeks
Change in Baseline Preparedness for Caregiving Scale Score at 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.	Change from baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	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).	Week 1
System Usability Scale	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).	Week 2
System Usability Scale	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).	Week 3
System Usability Scale	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).	Week 4
System Usability Scale	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).	Week 5
System Usability Scale	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).	Week 6

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Aging (NIA); Kaiser Permanente
• Investigators: Principal Investigator: Magaly Ramirez, PhD, MS, MS, University of Washington

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; Tauopathies; Dementia; Alzheimer Disease; Behavioral Symptoms; Caregiver Burden
• Other Study ID Numbers: STUDY00013410; 5U54AG063546-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No