Spanish Intervention for Caregivers of Veterans With Stroke

NCT03142841 | Completed Results

• 1 other identifier: IIR 15-117
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Burden; Problem Solving Ability; Caregivers; Stroke; Veterans

Outcome Measures

Primary Outcomes (2)

• Change in Caregiver Depression at 9 Weeks

  Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.

  9 weeks after baseline

• Change in Caregiver Depression at 21 Weeks

  Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.

  21 weeks after baseline

Secondary Outcomes (26)

• Change in Caregiver Burden-Zarit - 9 Weeks

  9 weeks

• Change in Caregiver Burden-Zarit - 21 Weeks

  21 weeks

• Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks

  9 weeks

• Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks

  21 weeks

• Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks

  9 weeks

Other Outcomes (6)

• Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks

  9 weeks

• Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks

  21 weeks

• Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks

  9 weeks

Study Arms (2)

Standard Care

NO INTERVENTION

The standard care group will receive the usual standard care they would receive had they not been enrolled in this study

Problem Solving Intervention

EXPERIMENTAL

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.

Other: RESCUE Problem Solving Intervention

Interventions

RESCUE Problem Solving Intervention OTHER

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.

Problem Solving Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Random assignment to the intervention or standard care group. The investigators will determine caregiver status.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

Location

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, 32803, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

VA Caribbean Healthcare System, San Juan, PR

San Juan, 00927-3200, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 36932321 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Testing the Impact of a Spanish Online and Telephone Intervention for Hispanic Caregivers of Veterans with Stroke

MeSH Terms

Conditions

Depression; Stroke

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study had no limitations or caveats.

Results Point of Contact

• Title: Dr. Ivette Magaly Freytes
• Organization: North Florida South Georgia Veterans Health System

ivette.freytes@va.gov

352-376-1611

Study Officials

• Ivette M Freytes, PhD MEd BA

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and data collectors will be blinded in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: January 1, 2018
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); PR (1)