Clinical trial NCT04633408: Cultural Adaptation of a Behavioral Intervention for Latino Caregivers
Official title: Cultural Adaptation of a Behavioral Intervention for Latino Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Latino
Caregiver
Cultural adaptation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2020-11-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A qualitative study, a participatory design study and a randomized pilot study to assess acceptability of an intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Acceptability
timeFrame: 2 months
measure: Acceptability
timeFrame: 2 months
measure: Acceptability
timeFrame: 2 months
measure: Potential Effectiveness
timeFrame: 2 months
measure: Potential Effectiveness
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lynnwood
country: United States
facility: Alzheimer's Association, Washington State Chapter
state: Washington
city: Seattle
country: United States
facility: UW Memory and Brain Wellness Clinic
state: Washington
Study officials:
References: