search
Back to results

Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

Primary Purpose

Alzheimer Disease, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAR-C Virtual Training and Follow-up (STAR-VTF)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer Disease focused on measuring Latino, Caregiver, Cultural adaptation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alzheimer's Association, Washington State ChapterRecruiting
  • UW Memory and Brain Wellness ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Acceptability
To assess acceptability, the investigators will measure: (1) app usage. The investigators will obtain data automatically collected by the platform to measure whether caregivers complete the training sessions, how many times caregivers visited the app, and the amount of time between app visits.
Acceptability
To assess acceptability, the investigators will measure (2) perceived ease-of-use. For perceived ease-of-use, the investigators will administer the System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (score 5) to Strongly disagree (score 1).
Acceptability
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
To assess potential effectiveness, the investigators will measure (1) caregiver burden. For caregiver burden, the investigators will administer the Screen for Caregiver Burden (SCB). The 25-item SCB, provides scores for objective burden (OB; number of potentially negative experiences) and subjective burden (SB; appraised distress in response to the experiences). OB scores caregiver experiences that have occurred, regardless of their distress; it scores each item as 0 (did not occur) or 1 (indicating occurrence). SB scores evaluate the distress associated with the experiences; it uses five anchor points: 0 = no occurrence of the experience: 1 = occurrence of the experience, but no distress; 2 = occurrence with mild distress; 3 = occurrence with moderate distress; and 4 = occurrence with severe distress.
Potential Effectiveness
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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2020
Last Updated
August 15, 2023
Sponsor
University of Washington
Collaborators
Alzheimer's Association
search

1. Study Identification

Unique Protocol Identification Number
NCT04633408
Brief Title
Cultural Adaptation of a Behavioral Intervention for Latino Caregivers
Official Title
Cultural Adaptation of a Behavioral Intervention for Latino Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Latino, Caregiver, Cultural adaptation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A qualitative study, a participatory design study and a randomized pilot study to assess acceptability of an intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
12 to 15 participants, will not have access to the app.
Intervention Type
Behavioral
Intervention Name(s)
STAR-C Virtual Training and Follow-up (STAR-VTF)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Acceptability
Description
To assess acceptability, the investigators will measure: (1) app usage. The investigators will obtain data automatically collected by the platform to measure whether caregivers complete the training sessions, how many times caregivers visited the app, and the amount of time between app visits.
Time Frame
2 months
Title
Acceptability
Description
To assess acceptability, the investigators will measure (2) perceived ease-of-use. For perceived ease-of-use, the investigators will administer the System Usability Scale. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (score 5) to Strongly disagree (score 1).
Time Frame
2 months
Title
Acceptability
Description
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).
Time Frame
2 months
Title
Potential Effectiveness
Description
To assess potential effectiveness, the investigators will measure (1) caregiver burden. For caregiver burden, the investigators will administer the Screen for Caregiver Burden (SCB). The 25-item SCB, provides scores for objective burden (OB; number of potentially negative experiences) and subjective burden (SB; appraised distress in response to the experiences). OB scores caregiver experiences that have occurred, regardless of their distress; it scores each item as 0 (did not occur) or 1 (indicating occurrence). SB scores evaluate the distress associated with the experiences; it uses five anchor points: 0 = no occurrence of the experience: 1 = occurrence of the experience, but no distress; 2 = occurrence with mild distress; 3 = occurrence with moderate distress; and 4 = occurrence with severe distress.
Time Frame
2 months
Title
Potential Effectiveness
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magaly Ramirez, PhD, MS, MS
Phone
206-543-9773
Email
maggiera@uw.edu
Facility Information:
Facility Name
Alzheimer's Association, Washington State Chapter
City
Lynnwood
State/Province
Washington
ZIP/Postal Code
98036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estela Ochoa
Facility Name
UW Memory and Brain Wellness Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimi Domoto, Dr.

12. IPD Sharing Statement

Learn more about this trial

Cultural Adaptation of a Behavioral Intervention for Latino Caregivers

We'll reach out to this number within 24 hrs