Spanish Intervention for Caregivers of Veterans With Stroke

Depression Clinical Trial

— RESCUE Espanol  

Official title:

Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03142841
• Other study ID #: IIR 15-117
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 227
• Est. completion date: September 30, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression

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.

Locations

Country	Name	City	State
Puerto Rico	VA Caribbean Healthcare System, San Juan, PR	San Juan
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
United States	Orlando VA Medical Center, Orlando, FL	Orlando	Florida
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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):S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Caregiver Depression	Caregiver depression as measured by the CESD-20	baseline, 9 weeks, and 20 weeks
Secondary	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
Secondary	Change in Caregiver Burden	as measured by the Zarit Burden instrument	baseline, 9 weeks, and 20 weeks
Secondary	Change in Caregiver Problem Solving Abilities	as measured by the Social Problem Solving Inventory - short form	baseline, 9 weeks, and 20 weeks
Secondary	Change in Caregiver Self-Efficacy	As measured by the Revised Scale for Caregiving Self-Efficacy	baseline, 9 weeks, and 20 weeks
Secondary	Change in Veterans's Functional Abilities	as reported by their caregivers on the Stroke Impact Scale	baseline, 9 weeks, and 20 weeks
Secondary	Change in Veteran's Healthcare Utilization	as reported by their caregivers	baseline, 9 weeks, and 20 weeks
Secondary	Change in Change in Veteran's Healthcare Utilization	as recorded through chart reviews	baseline, 9 weeks, and 20 weeks