NCT05599100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 21, 2024

Completed
Last Updated

August 21, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

October 23, 2022

Results QC Date

June 11, 2024

Last Update Submit

July 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • System Usability Scale

    Week 1

  • System Usability Scale

    Week 2

  • System Usability Scale

    Week 3

  • System Usability Scale

    Week 4

  • System Usability Scale

    Week 5

  • +1 more secondary outcomes

Study Arms (1)

STAR-VTF

EXPERIMENTAL

Participants will receive the STAR-VTF intervention.

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

Interventions

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).

STAR-VTF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • PLWD lives in assisted living or skilled nursing facilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (4)

  • 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.

    PMID: 1466831BACKGROUND
  • 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.

    PMID: 21294937BACKGROUND
  • 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.

    PMID: 33340272BACKGROUND
  • 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.

    PMID: 33325828BACKGROUND

MeSH Terms

Conditions

Caregiver BurdenAlzheimer DiseaseDementiaBehavioral Symptoms

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Magaly Ramirez, PhD, MS, MS
Organization
University of Washington School of Public Health, Department of Health Systems and Population Health

Study Officials

  • Magaly Ramirez, PhD, MS, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Public Health

Study Record Dates

First Submitted

October 23, 2022

First Posted

October 31, 2022

Study Start

May 5, 2023

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

August 21, 2024

Results First Posted

August 21, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations