Spanish Intervention for Caregivers of Veterans With Stroke (RESCUE Espanol)

Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Other: RESCUE Problem Solving Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927-3200
    • VA Caribbean Healthcare System, San Juan, PR
• United States
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • North Florida/South Georgia Veterans Health System, Gainesville, FL
    • Orlando, Florida, United States, 32803
      • Orlando VA Medical Center, Orlando, FL
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans' Hospital, Tampa, FL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Study participants will receive the usual standard care they would receive had they not been enrolled in this study
Experimental: Problem Solving Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ivette Magaly Freytes, PhD MEd BA, North Florida/South Georgia Veterans Health System, Gainesville, FL

Publications and helpful links

General Publications

• Freytes MI, 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): September 6, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Stroke; Veterans; Burden; Caregivers; Problem Solving Ability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IIR 15-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No