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Clinical Trials/NCT04633408
NCT04633408
Completed
Not Applicable

Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

University of Washington2 sites in 1 country21 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University of Washington
Enrollment
21
Locations
2
Primary Endpoint
Acceptability
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Magaly Ramirez

Assistant Professor, School of Public Health

University of Washington

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

Outcomes

Primary Outcomes

Acceptability

Time Frame: 2 months

To assess acceptability, the investigators will measure (3) perceived usefulness. For perceived usefulness, the investigators will administer the Perceived Usefulness Scale. It consists of a 6 item questionnaire, all items are measured on a 7-point Likert-type scale ranging from "strongly disagree" (score 1) to "strongly agree" (score 7).

Potential Effectiveness

Time Frame: 2 months

To assess potential effectiveness, the investigators will measure (2) caregiver depression. For caregiver depression, the investigators will use the full Patient Health Questionnaire (PHQ)-9. PHQ-9 is the major depressive disorder (MDD) module of the full PHQ. Used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. Scores each of the 9 Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.

Study Sites (2)

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