Trial Outcomes & Findings for Virtual Training for Latino Caregivers to Manage Symptoms of Dementia (NCT NCT05599100)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Change from baseline to 6 weeks

Results posted on

2024-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	STAR-VTF Participants will receive the STAR-VTF intervention. 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).
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 participants were excluded from the analysis (1 was lost to follow up and the other did not respond to follow up outcome assessment)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STAR-VTF n=16 Participants Participants will receive the STAR-VTF intervention. 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).
Age, Continuous	51.2 years STANDARD_DEVIATION 13.2 • n=16 Participants
Sex: Female, Male Female	12 Participants n=16 Participants
Sex: Female, Male Male	4 Participants n=16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants
Preparedness for Caregiving Scale	1.98 units on a scale STANDARD_DEVIATION 0.33 • n=14 Participants • 2 participants were excluded from the analysis (1 was lost to follow up and the other did not respond to follow up outcome assessment)
Revised Memory and Behavior Problem Checklist (Overall Caregiver Reaction)	40.40 units on a scale STANDARD_DEVIATION 16.48 • n=14 Participants • 2 participants were excluded from the analysis (1 was lost to follow up and the other did not respond to follow up outcome assessment)

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	STAR-VTF n=14 Participants Participants will receive the STAR-VTF intervention. 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).
Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks (Overall Caregiver Reaction)	-6.90 units on a scale Standard Deviation 14.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	STAR-VTF n=14 Participants Participants will receive the STAR-VTF intervention. 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).
Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks	0.63 score on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=13 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	77.8 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=12 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	77.7 units on a scale Standard Deviation 12.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=10 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	74.6 units on a scale Standard Deviation 19.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=13 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	73.7 units on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=12 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	75.8 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	STAR-VTF n=11 Participants Participants will receive the STAR-VTF intervention. 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).
System Usability Scale	79.2 units on a scale Standard Deviation 14.5

Adverse Events

STAR-VTF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Magaly Ramirez, PhD, MS, MS

University of Washington School of Public Health, Department of Health Systems and Population Health

Phone: 206-543-9773

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place