Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

NCT ID: NCT04633408

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-06-30

Brief Summary

The overall objectives of the proposed research are to: (i) develop a prototype of a smartphone application (app) that can deliver culturally adapted STAR-C training to Latino caregivers, and (ii) understand the extent to which a STAR-C app is acceptable and potentially effective among Latino caregivers. Achieving these objectives will lay the groundwork for a future full-scale trial to test the STAR-C app with Latino caregivers.

This study aims to: Adapt the STAR-C training to increase cultural relevance for Latino caregivers. The adaptations will focus on incorporating cultural examples, identities, values, beliefs, and practices within the training, as well as using cultural idioms, metaphors, and sayings to compliment explanations. Develop a prototype of a STAR-C app for Latino caregivers. The prototype will be iteratively developed with active participation from Latino caregivers. The final prototype will consist of a fully interactive app that delivers culturally relevant STAR-C training in an engaging and easy to use format. Assess the acceptability and potential effectiveness of the STAR-C app for Latino caregivers. Measures of acceptability will include app usage and perceived ease-of-use and usefulness of the STAR-C app. Measures of potential effectiveness will include changes in caregiver burden and depression.

Detailed Description

For aim 1, the investigators plan to recruit 25-30 participants with representation from both caregivers and providers. The investigators will recruit Latino Family Caregivers of persons with ADRD (Alzheimer's Disease and related Dementias). The investigators will recruit providers who work in an organization serving Latino elderly. Participants will be >18 years old.

For aim 2, the investigators will recruit 5 caregivers per session. With three iterative design sessions, the investigators anticipate 15 caregivers in total. The investigators will use the same eligibility criteria described for aim 1.

For aim 3, the investigators will recruit 15 Latino caregivers for each study arm (total sample size of 30). The investigators based the sample size on a rule of thumb of 12 to 15 participants per group for pilot studies. The investigators will use the same eligibility criteria and recruitment strategy described for aim 1

Conditions

Alzheimer Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

The investigators will recruit 15 Latino caregivers for each study arm (total sample size of 30). The sample size was based on a rule of thumb of 12 to 15 participants per group for pilot studies. This group will have access to the app.

Group Type: EXPERIMENTAL

STAR-C Virtual Training and Follow-up (STAR-VTF)

Intervention Type: BEHAVIORAL

STAR-C Virtual Training and Follow-up (STAR-VTF) is adapted from an evidence-based, in-person program that trains family caregivers to manage BPSD (behavioral and psychological symptoms of dementia)

Control

12 to 15 participants, will not have access to the app.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STAR-C Virtual Training and Follow-up (STAR-VTF)

STAR-C Virtual Training and Follow-up (STAR-VTF) is adapted from an evidence-based, in-person program that trains family caregivers to manage BPSD (behavioral and psychological symptoms of dementia)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Family member or close friend of a person with ADRD
• Provide at least eight hours of care per week Speak English or Spanish
• Self-identify as Latino.

Exclusion Criteria

• Caregiver who has a diagnosis of ADRD

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Magaly Ramirez

Assistant Professor, School of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alzheimer's Association, Washington State Chapter

Lynnwood, Washington, United States

UW Memory and Brain Wellness Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00009534

Identifier Type: -

Identifier Source: org_study_id