Spanish Intervention for Caregivers of Veterans With Stroke

ID: NCT03142841
Status: Recruiting
Phase: N/A
Start Date: January 01, 2018
First Submitted: May 01, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: Puerto Rico, United States
Conditions: Depression
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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: caregivers of Veterans with a primary diagnosis of stroke who have received services from the VA CHS 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 six months and who has at least two activity of daily living (ADL) deficits, 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) self-identify as Hispanic/Puerto Rican, and 7) agree to random assignment to the intervention or standard care group.

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.
Condition or disease Intervention/treatment Phase

Depression
Other: RESCUE Problem Solving Intervention
Other Names
N/A

Tracking Information

First Submitted DateMay 01, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateJanuary 01, 2018
Anticipated Completion DateSeptember 30, 2021
Actual Primary Completion DateJuly 01, 2021
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in Caregiver Depression [Time Frame: baseline, 9 weeks, and 20 weeks]

    Caregiver depression as measured by the CESD-20

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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)

  • Change in Caregiver Burden [Time Frame: baseline, 9 weeks, and 20 weeks]

    as measured by the Zarit Burden instrument

  • Change in Caregiver Problem Solving Abilities [Time Frame: baseline, 9 weeks, and 20 weeks]

    as measured by the Social Problem Solving Inventory - short form

  • Change in Caregiver Self-Efficacy [Time Frame: baseline, 9 weeks, and 20 weeks]

    As measured by the Revised Scale for Caregiving Self-Efficacy

  • Change in Veterans's Functional Abilities [Time Frame: baseline, 9 weeks, and 20 weeks]

    as reported by their caregivers on the Stroke Impact Scale

  • Change in Veteran's Healthcare Utilization [Time Frame: baseline, 9 weeks, and 20 weeks]

    as reported by their caregivers

  • Change in Change in Veteran's Healthcare Utilization [Time Frame: baseline, 9 weeks, and 20 weeks]

    as recorded through chart reviews

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSpanish Intervention for Caregivers of Veterans With Stroke
Official TitleSpanish Online & Telephone Intervention for Caregivers of Veterans With Stroke
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: caregivers of Veterans with a primary diagnosis of stroke who have received services from the VA CHS 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 six months and who has at least two activity of daily living (ADL) deficits, 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) self-identify as Hispanic/Puerto Rican, and 7) agree to random assignment to the intervention or standard care group.

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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
580
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Supportive Care
Conditions
Depression
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
Study Groups/Cohorts
Standard Care
Study participants will receive the usual standard care they would receive had they not been enrolled in this study

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.

Study Arms
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.

Arm Intervention/Treatment
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment580
Completion DateSeptember 30, 2021
Eligibility Criteria: Inclusion Criteria:
All caregivers of Veterans with a primary diagnosis of stroke who have received services from the VA CHS are eligible for participation if they meet the following criteria
- 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 six months and who has at least two activity of daily living (ADL) deficits
- have Internet access and ability (either themselves or via a relative or friend)
- are reachable by cell or home phone
- Spanish is their preferred language
- have moderate to severe stress
- self-identify as Hispanic/Puerto Rican
- agree to random 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 and:
- are managing end-of-life issues (stroke survivors are likely to die within five months following discharge)
- whose stroke survivors enrolled in home-based primary care or a telehealth program.
GenderAll
Age N/A to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
Puerto Rico
United States

Administrative Information

NCT Number:NCT03142841
Other Study ID Numbers
IIR 15-117
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Ivette Magaly Freytes, PhD MEd BA
North Florida/South Georgia Veterans Health System, Gainesville, FL