Study protocol of a telephone problem-solving intervention for Spanish-speaking caregivers of veterans post-stroke: an 8-session investigator-blinded, two-arm parallel (intervention vs usual care), randomized clinical trial

BMC Primary Care

Study Protocol

Samuel S. Wu¹  Constance R. Uphold²  Keryl Motta-Valencia³  Tatiana Orozco⁴  Jennifer H. LeLaurin⁴  Janet Lopez⁴  Magda K. Schmitzberger⁴  Jennifer Hale-Gallardo⁴  Nathaniel Eliazar-Macke⁴  I. Magaly Freytes⁵  Naiomi Rivera-Rivera⁶ 

[1] College of Medicine, Department of Biostatistics, University of Florida, CTRB Room 5243, 2004 Mowry Road, 32610, Gainesville, FL, USA;Geriatric Research Education and Clinical Center, North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd #151B, 32608, Gainesville, FL, USA;College of Medicine, Department of Aging and Geriatric Research, University of Florida, 2004 Mowry Rd, 32603, Gainesville, FL, USA;Physical Medicine and Rehabilitation Service, VA Caribbean Healthcare System, 10 Casia St, 00921, San Juan, PR, USA;Research Service, North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd #151B, 32608, Gainesville, FL, USA;Research Service, North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd #151B, 32608, Gainesville, FL, USA;Geriatric Research Education and Clinical Center, North Florida/South Georgia Veterans Health System, 1601 SW Archer Rd #151B, 32608, Gainesville, FL, USA;Research Service, VA Caribbean Healthcare System, 10 Casia St, 00921, San Juan, PR, USA;

关键词: Hispanic Americans;    Veterans;    Caregiver Burden;    Stroke Caregiving;    Problem-solving;    Depression;    Culturally-relevant Intervention;    Health Education;    Quality of Life;    Minority Health;   

DOI  :  10.1186/s12875-022-01929-y

 received in 2022-10-19, accepted in 2022-11-25,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundStroke is one of the leading causes of death and the main cause of long-term disability in the United States. The significant risk factors of stroke among Hispanics are well-documented. The majority of stroke survivors return home following a stroke and are cared for by family caregivers. Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands that oftentimes lead to caregiver burden and depression. Given the significant risk factors for stroke in Hispanics and the influence of culture in family norms and family management, we developed a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers. This study tests the impact of a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers on caregiver outcomes.MethodsThe design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 290 caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a problem-solving intervention that uses telephone and online education and care management tools on the previously developed and nationally available RESCUE en Español Caregiver website. In the usual care group, participants receive the information and/or support caregivers of veterans with stroke normally receive through existing VA resources (e.g., stroke-related information and support). The primary outcome is change in caregiver’s depressive symptoms at 1- and 12-weeks post-intervention. Secondary outcomes include changes in stroke caregivers’ burden, self-efficacy, problem-solving, and health-related quality of life (HRQOL) and veterans’ functional abilities. We will also determine the budgetary impact, the acceptability of the intervention and participation barriers and facilitators for Spanish-speaking stroke caregivers.DiscussionThis is an ongoing study. It is the first known randomized controlled trial testing the effect of a telephone and online problem-solving intervention in Spanish for caregivers of veterans post-stroke. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post-stroke.Trial registrationClinicalTrials.gov: NCT03142841— Spanish Intervention for Caregivers of Veterans with Stroke (RESCUE Español). Registered on February 23, 2018. Protocol version 8. 08.11.2022.

【 授权许可】

CC BY   
© This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023

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