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Customized Employment for Spinal Cord Injury (ACCESS-Vets Trial)
N/A
Recruiting
Led By Lisa Ottomanelli, PhD
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
18-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Awards & highlights
ACCESS-Vets Trial Summary
This trial is being done to study whether an innovative employment strategy, Customized Employment, can help Veterans with Spinal Cord Injuries (SCI) find and maintain competitive integrated employment.
Who is the study for?
This trial is for English-speaking Veterans aged 18-65 with spinal cord injury who want to work in their community. They must be living within a two-hour drive from the VAMC, not have progressive disorders like multiple sclerosis, severe brain injuries, psychosis treated in the last 6 months, untreated substance abuse, or impairments that prevent consent.Check my eligibility
What is being tested?
The study tests whether Customized Employment (ACCESS-Vets) can help Veterans with SCI find and keep jobs better than the usual job support program (IPS). Participants will be randomly assigned to either ACCESS-Vets or IPS and followed for about 8 months.See study design
What are the potential side effects?
Since this trial involves employment interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience stress or anxiety related to job search and employment activities.
ACCESS-Vets Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
ACCESS-Vets Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Employment Status
Secondary outcome measures
Adaption of Intervention- Benchmarks of Quality Checklist (BQC)
Change in Employment Barriers- Employment Questionnaire
Change in Employment Barriers- Qualitative Interview -Provider participants
+11 moreACCESS-Vets Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ACCESS-Vets Intervention GroupExperimental Treatment1 Intervention
This group will receive ACCESS-Vets, a customized employment intervention adapted for use in VA healthcare.
Group II: IPS (Usual Care) GroupActive Control1 Intervention
This group will receive IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACCESS
2017
N/A
~800
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,084 Total Patients Enrolled
Lisa Ottomanelli, PhDPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL
2 Previous Clinical Trials
1,296 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Veterans who have trouble seeing, hearing, or thinking clearly and cannot understand or take part in important parts of the study.Veterans who have received or are currently receiving care from a specific VA provider.It seems like the given phrase is incomplete or not clearly related to clinical trial exclusion criteria. Could you please provide more context or clarify the request?You have already received or are currently receiving treatment from a specific healthcare provider.I am a veteran with a serious brain injury, rated Rancho Level 6 or lower.I am a Veteran aged 18-65, live in my own place, and speak English.Veterans who have not received treatment for substance use disorder.I live more than two hours away from the Veterans Affairs Medical Center.I am a veteran treated for psychosis in the last 6 months.I am a veteran seeking employment in my community.I am a veteran living at home and speak English.I am a veteran with a worsening spinal condition or a terminal illness like multiple sclerosis.This criterion does not seem to be related to a clinical trial exclusion criteria. Can you please provide a clinical trial exclusion criteria that I can simplify for you?This criterion refers to healthcare providers and other team members involved in spinal cord injury care.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: ACCESS-Vets Intervention Group
- Group 2: IPS (Usual Care) Group
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 there an age requirement for participating in this experiment?
"To meet the eligibility criteria for this experiment, individuals must be situated between 18 and 65 years of age."
Answered by AI
How many people are engaged in this trial?
"Affirmative. Clinicaltrials.gov indicates that, following its posting on February 14th 2022, this research project is actively recruiting participants from 2 sites with the aim of sourcing 100 individuals in total."
Answered by AI
Who is eligible to take part in this clinical trial?
"This medical investigation is seeking 100 candidates with spinal cord impairments who are of legal age (18-65)."
Answered by AI
Are there currently any openings for this clinical trial?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which was initially posted on February 14th 2022, is currently enrolling subjects. A total of 100 participants are expected to be recruited between two health centers."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
James A. Haley Veterans' Hospital, Tampa, FL
Hunter Holmes McGuire VA Medical Center, Richmond, VA
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I have only used 2 drugs, baclafin and pregabalin, and they have not helped my spinal cord injury and I am not a veteran.
PatientReceived 2+ prior treatments
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