Spanish Intervention for Caregivers of Veterans With Stroke
NCT ID: NCT03142841
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2018-01-01
2024-03-04
Brief Summary
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Detailed Description
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The investigators will conduct a two-arm (8-session intervention vs. standard care), , randomized controlled trial to test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. A sample of 290 stroke caregivers will be randomly assigned to either an intervention or a standard care group. Eligibility criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. We will determine caregiver status.
Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via Computerized Patient Record System (CPRS) electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention. A general linear mixed model for repeated measures will be used to examine the relationship between treatment assignment and each outcome over time. The investigators will measure the budgetary impact of providing intervention by comparing the costs of the intervention group to the costs of the control group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Standard Care
The standard care group will receive the usual standard care they would receive had they not been enrolled in this study
No interventions assigned to this group
Problem Solving Intervention
Participants in the intervention group received an 8-week problem-solving session conducted over the phone by a trainer interventionist. The intervention consists of four components: 1. Introduction to the RESCUE website and the problem-solving method; 2. Illustrative example on how to use the problem-solving approach and the RESCUE website to address caregiving problems; 3. Individualized practice exercise to develop a personalized problem-solving plan; and 4. Summary of the problem-solving method.
RESCUE Problem Solving Intervention
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs.
Interventions
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RESCUE Problem Solving Intervention
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs.
Eligibility Criteria
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Inclusion Criteria
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Ivette M Freytes, PhD MEd BA
Role: PRINCIPAL_INVESTIGATOR
North Florida/South Georgia Veterans Health System, Gainesville, FL
Locations
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North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States
VA Caribbean Healthcare System, San Juan, PR
San Juan, , Puerto Rico
Countries
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References
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Freytes IM, Schmitzberger MK, Rivera-Rivera N, Lopez J, Motta-Valencia K, Wu SS, Orozco T, Hale-Gallardo J, Eliazar-Macke N, LeLaurin JH, Uphold CR. 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 Prim Care. 2023 Mar 17;24(1):73. doi: 10.1186/s12875-022-01929-y.
Freytes IM, Schmitzberger M, Rivera-Rivera N, Lopez J, Mylott D, Motta-Valencia K, Uphold CR. Serving Underserved Veterans and Their Caregiver: Developing Tailored Culturally Relevant Interventions. [Abstract]. Innovation in aging. 2019 Nov 8; 3(Supp 1):S674.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Testing the Impact of a Spanish Online and Telephone Intervention for Hispanic Caregivers of Veterans with Stroke
Other Identifiers
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IIR 15-117
Identifier Type: -
Identifier Source: org_study_id