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Spanish Intervention for Caregivers of Veterans With Stroke (RESCUE Espa ol)

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ClinicalTrials.gov Identifier: NCT03142841
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Depression Other: RESCUE Problem Solving Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: The PI and data collectors will be blinded in this study.
Primary Purpose: Supportive Care
Official Title: Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.




Primary Outcome Measures :
  1. Change in Caregiver Depression [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    Caregiver depression as measured by the CESD-20


Secondary Outcome Measures :
  1. Change in Caregiver Health Related Quality of Life [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as measured by the Veterans RAND 12 Item Health Survey (VR-12)

  2. Change in Caregiver Burden [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as measured by the Zarit Burden instrument

  3. Change in Caregiver Problem Solving Abilities [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as measured by the Social Problem Solving Inventory - short form

  4. Change in Caregiver Self-Efficacy [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    As measured by the Revised Scale for Caregiving Self-Efficacy

  5. Change in Veterans's Functional Abilities [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as reported by their caregivers on the Stroke Impact Scale

  6. Change in Veteran's Healthcare Utilization [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as reported by their caregivers

  7. Change in Change in Veteran's Healthcare Utilization [ Time Frame: baseline, 9 weeks, and 20 weeks ]
    as recorded through chart reviews



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142841


Contacts
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Contact: Ivette M Freytes, PhD MEd BA (352) 264-3836 ext 201240 Ivette.Freytes@va.gov
Contact: Magda K Schmitzberger, MPH BSH (352) 264-7364 magda.schmitzberger@va.gov

Locations
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United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Ivette M Freytes, PhD MEd BA    (352) 264-3836 ext 201240    Ivette.Freytes@va.gov   
Contact: Magda K Schmitzberger, MPH BSH    (352) 264-7364    magda.schmitzberger@va.gov   
Sub-Investigator: Constance R. Uphold, PhD MS BS         
Principal Investigator: Ivette Magaly Freytes, PhD MEd BA         
Sub-Investigator: Jennifer Lynn Hale-Gallardo, PhD MS BS         
Sub-Investigator: Sergio Romero, PhD MS BS         
Sub-Investigator: Tatiana Schember Orozco, PhD MS BS         
Orlando VA Medical Center, Orlando, FL Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Adam Golden, MD    407-631-4022    Adam.Golden@va.gov   
Contact: Magda Schmitzberger    3522647364    magda.schmitzberger@va.gov   
James A. Haley Veterans' Hospital, Tampa, FL Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Linda Cowan, PhD    813-558-3932    Linda.Cowan@va.gov   
Contact: Magda Schmitzberger, MPH    3522647364    magda.schmitzberger@va.gov   
Puerto Rico
VA Caribbean Healthcare System, San Juan, PR Recruiting
San Juan, Puerto Rico, 00921
Contact: Keryl Motta-Valencia, MD    (787) 641-2907    keryl.mottavalencia@va.gov   
Contact: Jorge L Martinez-Martino, MPH    (787) 641-7582 ext 10129    Jorge.Martinez-Martino@va.gov   
Sub-Investigator: Keryl Motta-Valencia, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ivette Magaly Freytes, PhD MEd BA North Florida/South Georgia Veterans Health System, Gainesville, FL

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03142841     History of Changes
Other Study ID Numbers: IIR 15-117
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Depression
Burden
Problem Solving Ability
Caregivers
Stroke
Veterans
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms