Spanish Intervention for Caregivers of Veterans With Stroke

Study Overview
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Brief Summary
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This research study will 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. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.

Detailed Description
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This research study will 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. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention. 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 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.

Official Title
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Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke

Conditions
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Depression

Intervention / Treatment
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* Other: RESCUE Problem Solving Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion 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. andom assignment to the intervention or standard care group. The investigators will determine caregiver status. Exclusion Criteria: The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-arm (8-session intervention vs. standard care), randomized controlled clinical trial with three assessment points will be conducted. 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 CPRS electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Study participants will receive the usual standard care they would receive had they not been enrolled in this study | |
| Experimental: Problem Solving Intervention<br>The intervention consists of a problem-solving intervention and information/tools on the previously developed, evidenced-based Spanish-version of the RESCUE stroke caregiver website to improve stroke caregiver outcomes. The intervention will be conducted via telephone by a trained rehabilitation counselor. 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. | Other: RESCUE Problem Solving Intervention<br>* This is an education and support intervention for caregivers of Veterans with stroke. The investigators will teach study participants about the COPE model of problem solving and guide them through the application of this model in their caregiver role. They will receive tailored stroke education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver Depression | Caregiver depression as measured by the CESD-20 | baseline, 9 weeks, and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver Health Related Quality of Life | as measured by the Veterans RAND 12 Item Health Survey (VR-12) | baseline, 9 weeks, and 20 weeks | 
| Change in Caregiver Burden | as measured by the Zarit Burden instrument | baseline, 9 weeks, and 20 weeks | 
| Change in Caregiver Problem Solving Abilities | as measured by the Social Problem Solving Inventory - short form | baseline, 9 weeks, and 20 weeks | 
| Change in Caregiver Self-Efficacy | As measured by the Revised Scale for Caregiving Self-Efficacy | baseline, 9 weeks, and 20 weeks | 
| Change in Veterans's Functional Abilities | as reported by their caregivers on the Stroke Impact Scale | baseline, 9 weeks, and 20 weeks | 
| Change in Veteran's Healthcare Utilization | as reported by their caregivers | baseline, 9 weeks, and 20 weeks | 
| Change in Change in Veteran's Healthcare Utilization | as recorded through chart reviews | baseline, 9 weeks, and 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Burden, Problem Solving Ability, Caregivers, Stroke, Veterans