4134 — Methodology of a RCT testing the impact of a Spanish Online and Telephone Intervention for Hispanic Caregivers of Veterans with Stroke

Lead/Presenter: Melanie Orejuela, 
All Authors: Orejuela M (North Florida/South Georgia VHS), Lopez J (North Florida/South Georgia VHS) Rivera-Rivera N (VA Caribbean Health Care System) Uphold C (North Florida/South Georgia VHS) Eliazar-Macke N (North Florida/South Georgia VHS) Findley K (North Florida/South Georgia VHS) Galindo P (North Florida/South Georgia VHS) Freytes, IM North Florida/South Georgia VHS

Objectives:
Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands. Traditionally, Hispanic caregivers report higher rates of negative caregiver outcomes. We describe the methodology used in an ongoing randomized control trial targeting Spanish-speaking Hispanic caregivers of Veterans post-stroke.

Methods:
This is a two-arm parallel randomized clinical trial with repeated measures that uses mixed methods. Target enrollment is 290 stroke caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive an 8-session telephone problem-solving intervention and online education previously developed for a nationally available RESCUE en Espanol website. Participants in the standard care arm receive care normally provided through existing VA resources. The primary outcome is caregiver’s depression at 8- and 12-weeks post-baseline. Secondary outcomes include changes in stroke caregivers’ burden, self-efficacy, problem-solving, and health-related quality of life and veterans’ functional abilities. We will also determine the budgetary impact, assess the intervention’s acceptability as well as barriers and facilitators. We employed a rigorous cultural adaption consisting of a dynamic and reiterative process with stakeholders. The intervention and the online RESCUE website are an adaptation of a previous intervention, Resources and Education for Stroke Caregivers' Understanding and Empowerment. To ensure cultural relevancy for Hispanics, we used several sources to inform the adaptation of the RESCUE en Espanol intervention including reaching consensus among an interdisciplinary team of experts in stroke caregiving and Hispanic Veterans and families.

Results:
To date, we have enrolled 159 participants in this ongoing randomized controlled trial with 106 completed and 36 withdrawn. Due to natural disasters in our original recruitment site Puerto Rico, and the COVID-19 pandemic, several modifications had been implemented to address challenges such as adding 2 new recruitment sites and requesting cost and time extensions. Data analysis is set to begin mid-2023.

Implications:
This is the first known randomized control trial to investigate a telephone and online problem-solving intervention combined with the nationally available Spanish- language, evidence-based RESCUE website. The intervention has the potential to reduce stroke caregiver depression, improve recovery of Veterans post-stroke, enable Veterans to remain in their homes, and reduce healthcare costs.

Impacts:
Developing evidence-based culturally relevant caregiver interventions may be transportable to other populations and disease models and thus enable Veterans to remain at home while reducing costs. This will help identify novel interventions that can be implemented to reduce disparities for caregivers of Veterans with stroke that are sustainable in routine clinical practice and improve access to high-quality health care of minority Veterans.