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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RESCUE Problem Solving Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Depression, Burden, Problem Solving Ability, Caregivers, Stroke, Veterans

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
  • Orlando VA Medical Center, Orlando, FLRecruiting
  • James A. Haley Veterans' Hospital, Tampa, FLRecruiting
  • VA Caribbean Healthcare System, San Juan, PRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Problem Solving Intervention

Arm Description

Study participants will receive the usual standard care they would receive had they not been enrolled in this study

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.

Outcomes

Primary Outcome Measures

Change in Caregiver Depression
Caregiver depression as measured by the CESD-20

Secondary Outcome Measures

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

Full Information

First Posted
May 1, 2017
Last Updated
April 14, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03142841
Brief Title
Spanish Intervention for Caregivers of Veterans With Stroke
Acronym
RESCUE Espanol
Official Title
Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 23, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Burden, Problem Solving Ability, Caregivers, Stroke, Veterans

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The PI and data collectors will be blinded in this study.
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Study participants will receive the usual standard care they would receive had they not been enrolled in this study
Arm Title
Problem Solving Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
RESCUE Problem Solving Intervention
Intervention Description
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 Measure Information:
Title
Change in Caregiver Depression
Description
Caregiver depression as measured by the CESD-20
Time Frame
baseline, 9 weeks, and 20 weeks
Secondary Outcome Measure Information:
Title
Change in Caregiver Health Related Quality of Life
Description
as measured by the Veterans RAND 12 Item Health Survey (VR-12)
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Caregiver Burden
Description
as measured by the Zarit Burden instrument
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Caregiver Problem Solving Abilities
Description
as measured by the Social Problem Solving Inventory - short form
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Caregiver Self-Efficacy
Description
As measured by the Revised Scale for Caregiving Self-Efficacy
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Veterans's Functional Abilities
Description
as reported by their caregivers on the Stroke Impact Scale
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Veteran's Healthcare Utilization
Description
as reported by their caregivers
Time Frame
baseline, 9 weeks, and 20 weeks
Title
Change in Change in Veteran's Healthcare Utilization
Description
as recorded through chart reviews
Time Frame
baseline, 9 weeks, and 20 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Orejuela, BS
Phone
(352) 376-1611
Email
melanie.orejuela@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Ivette M Freytes, PhD MEd BA
Phone
(352) 264-3836
Ext
201240
Email
Ivette.Freytes@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivette Magaly Freytes, PhD MEd BA
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivette M Freytes, PhD MEd BA
Phone
(352) 264-3836
Ext
201240
Email
Ivette.Freytes@va.gov
First Name & Middle Initial & Last Name & Degree
Melanie Orejuela, BS
Phone
(352) 376-1611
Email
melanie.orejuela@va.gov
First Name & Middle Initial & Last Name & Degree
Constance R. Uphold, PhD MS BS
First Name & Middle Initial & Last Name & Degree
Ivette Magaly Freytes, PhD MEd BA
First Name & Middle Initial & Last Name & Degree
Jennifer Lynn Hale-Gallardo, PhD MS BS
First Name & Middle Initial & Last Name & Degree
Sergio Romero, PhD MS BS
First Name & Middle Initial & Last Name & Degree
Tatiana Schember Orozco, PhD MS BS
Facility Name
Orlando VA Medical Center, Orlando, FL
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Golden, MD
Phone
407-631-4022
Email
Adam.Golden@va.gov
First Name & Middle Initial & Last Name & Degree
Magda Schmitzberger
Phone
3522647364
Email
magda.schmitzberger@va.gov
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Cowan, PhD
Phone
813-558-3932
Email
Linda.Cowan@va.gov
First Name & Middle Initial & Last Name & Degree
Magda Schmitzberger, MPH
Phone
3522647364
Email
magda.schmitzberger@va.gov
Facility Name
VA Caribbean Healthcare System, San Juan, PR
City
San Juan
ZIP/Postal Code
00927-3200
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keryl Motta-Valencia, MD
Phone
(787) 641-7582
Ext
11043
Email
keryl.mottavalencia@va.gov
First Name & Middle Initial & Last Name & Degree
Jorge L Martinez-Martino, MPH
Phone
(787) 641-7582
Ext
10129
Email
Jorge.Martinez-Martino@va.gov
First Name & Middle Initial & Last Name & Degree
Jorge Martinez-Diaz
First Name & Middle Initial & Last Name & Degree
Keryl Motta-Valencia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result

Learn more about this trial

Spanish Intervention for Caregivers of Veterans With Stroke

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