Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05599100
Other study ID # STUDY00013410
Secondary ID 5U54AG063546-04
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 15, 2024
Est. primary completion date January 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


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).

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Kaiser Permanente, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Baseline Revised Memory and Behavior Problem Checklist Score at 6 Weeks Caregivers will rate memory, depression, and disruptive behavior problems in people living with dementia. The instrument contains 24 items (7 memory-related, 8 depressive, and 9 disruptive) that assess problem behaviors and are rated for frequency of occurrence during the past week and caregiver reaction to the problem behaviors. Change from baseline to 6 weeks
Primary Change in Baseline Preparedness for Caregiving Scale Score at 6 Weeks Caregivers will 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 5 (very well prepared). Change from baseline to 6 weeks
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 1
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 2
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 3
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 4
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 5
Secondary System Usability Scale Caregivers will rate how easy the online training modules are to use. The instrument contains 10 items. Each item is rated on a 5-point scale ranging from 0 (strongly disagree) to 7 (strongly agree). Week 6
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A