Caregiver BurdenNCT05599100

Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

A study testing STAR-Caregivers Virtual Training & Follow-up (STAR-VTF) in people with Caregiver Burden and Alzheimer Disease, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Caregiver Burden, Alzheimer Disease, Dementia
What is being tested?: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 5 May 2023to 15 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

PLWD lives in assisted living or skilled nursing facilities

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

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.

Read the 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.

Conditions: Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms
Being tested: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)
Medical subject headings: Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05599100
Study group	Role	What they receive
STAR-VTF	Experimental	Participants will receive the STAR-VTF intervention. Receives: Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Change from baseline to 6 weeks

Secondary outcomes (6)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202315 Jan 2024

First posted31 Oct 2022
Study start5 May 2023
Primary completion15 Jan 2024
Study completion15 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Caregiver BurdenStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05599100
Sponsor's protocol ID: STUDY00013410
Other IDs: 5U54AG063546-04
Status last verified: Jul 2024
First submitted: 23 Oct 2022
Last updated: 21 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 1466831
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.
PubMed 21294937
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.
PubMed 33340272
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.
PubMed 33325828

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Training for Latino Caregivers to Manage Symptoms of Dementia
ClinicalTrials.gov ID: NCT05599100
Acronym / sponsor ID: STUDY00013410
Conditions: Caregiver Burden, Alzheimer Disease, Dementia, Behavioral Symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Kaiser Permanente, National Institute on Aging (NIA)
Study start: 5 May 2023 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 15 Jan 2024 (actual)
First posted: 31 Oct 2022 (actual)
Results: Posted 21 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
STAR-VTF	Experimental	Behavioral: STAR-Caregivers Virtual Training & Follow-up (STAR-VTF)Participants will receive the STAR-VTF intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

PLWD lives in assisted living or skilled nursing facilities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Behavioural	STAR-VTF

Primary outcome

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.
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.

6 secondary outcomes

System Usability Scale
Time frame: Week 1
System Usability Scale
Time frame: Week 2
System Usability Scale
Time frame: Week 3
System Usability Scale
Time frame: Week 4
System Usability Scale
Time frame: Week 5
System Usability Scale
Time frame: Week 6

Results and safety

Results posted to the registry on 21 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STAR-VTF	16	15

Primary outcome: Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks (Overall Caregiver Reaction)

Time frame: Change from baseline to 6 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	STAR-VTF n = 14
Value	-6.90 (14.35)

Primary outcome: Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks

Time frame: Change from baseline to 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	STAR-VTF n = 14
Value	0.63 (0.73)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STAR-VTF	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1466831Teri 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.
Background: PubMed 21294937Salvia 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.
Background: PubMed 33340272Gutierrez-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.
Background: PubMed 33325828Sevilla-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Magaly Ramirez, PhD, MS, MS principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing STAR-Caregivers Virtual Training & Follow-up (STAR-VTF) in people with Caregiver Burden and Alzheimer Disease, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599100, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.