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Problem-Solving Intervention for Stroke Caregivers (RESCUE Espanol Trial)
N/A
Waitlist Available
Led By Ivette Magaly Freytes, PhD MEd BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9 weeks, and 20 weeks
Awards & highlights
RESCUE Espanol Trial Summary
This trial will test a problem-solving intervention for Spanish-speaking stroke caregivers, delivered over the telephone and online. The goal is to reduce caregiver burden and depression, and improve caregivers' problem-solving abilities, self-efficacy, and quality of life.
Who is the study for?
This trial is for Hispanic caregivers who primarily speak Spanish and are the main caregiver for a Veteran with stroke diagnosed within the last year, having significant daily activity challenges or worsening neurological issues. They must have moderate to severe stress, internet access, phone availability, and agree to be randomly assigned to either the intervention or standard care group.Check my eligibility
What is being tested?
The study tests a culturally-tailored problem-solving intervention delivered by phone and online aimed at reducing caregiver burden and depression while improving their problem-solving skills, self-efficacy, quality of life, as well as the functional abilities of Veterans they care for.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on problem-solving skills via telephone and online resources, traditional physical side effects associated with medications are not expected. However, participants may experience emotional discomfort discussing personal issues.
RESCUE Espanol Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 9 weeks, and 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9 weeks, and 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Caregiver Depression
Secondary outcome measures
Change in Caregiver Burden
Change in Caregiver Health Related Quality of Life
Change in Caregiver Problem Solving Abilities
+4 moreRESCUE Espanol Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Problem Solving InterventionExperimental Treatment1 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.
Group II: Standard CareActive Control1 Intervention
Study participants will receive the usual standard care they would receive had they not been enrolled in this study
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,376 Total Patients Enrolled
76 Trials studying Depression
20,462 Patients Enrolled for Depression
Ivette Magaly Freytes, PhD MEd BAPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a Hispanic caregiver for a Veteran who had a stroke within the last year, I'm stressed, and can access the Internet.You are experiencing a high level of stress, which is causing significant difficulties in your daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: Problem Solving Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this trial still open?
"Yes, according to the information provided on clinicaltrials.gov this experiment is seeking participants at present. The trial was first announced in January 2018 and last updated on June 16th 2022."
Answered by AI
How many people can participate in this clinical trial at the most?
"That is correct. Clinicaltrials.gov declares that this clinical trial, initially posted on January 1st 2018, is presently accepting participants. A total of 290 patients are needed from 3 separate healthcare facilities."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Orlando VA Medical Center, Orlando, FL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
clinical trial may help.
PatientReceived 1 prior treatment
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