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Collaborative Specialty Care for Gulf War Syndrome

N/A
Recruiting
Led By Lisa Marie McAndrew, 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
Rates their activity limitations from pain at least 3 on a 0 to 10 point scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 month
Awards & highlights

Study Summary

This trial will test whether a coordinated care team, including a physician champion, can improve the care and satisfaction of Gulf War Veterans with Gulf War Illness.

Who is the study for?
This trial is for Gulf War Veterans who served in Operation Desert Shield/Storm and meet the Kansas City (Steele) definition of Gulf War Illness. They should experience pain that limits their activities, rating at least a 3 out of 10 on a pain scale, and must have a VA primary care provider. Those with suicidal intent or previous specialized evaluations or participation in related trials are excluded.Check my eligibility
What is being tested?
The study is testing Collaborative Specialty Care versus standard care to improve treatment delivery for veterans with Gulf War Illness. It will use e-consultation methods to see if this improves satisfaction and health outcomes compared to current practices within the VA system.See study design
What are the potential side effects?
Since this trial focuses on models of care rather than medication, traditional side effects like those seen with drugs are not applicable. However, participants may experience discomfort from changes in their routine healthcare management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain limits my activities at a level of 3 or more on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Brief Pain Inventory - Interference Scale
Patient Activation Measure
Patient Health Questionnaire Somatic Symptom Scale - 15
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: collaborative specialty careExperimental Treatment1 Intervention
In specialty collaborative care, the specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the primary care team make monthly optimization of analgesics.
Group II: e-consultationActive Control1 Intervention
In e-consultation the specialty provider team will make a onetime recommendation to the primary care team that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,209 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
128 Patients Enrolled for Gulf War Syndrome
Lisa Marie McAndrew, PhDPrincipal InvestigatorEast Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
2 Previous Clinical Trials
598 Total Patients Enrolled
Justeen K Hyde, PhDPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA

Media Library

Collaborative Specialty Care Clinical Trial Eligibility Overview. Trial Name: NCT04403295 — N/A
Gulf War Syndrome Research Study Groups: e-consultation, collaborative specialty care
Gulf War Syndrome Clinical Trial 2023: Collaborative Specialty Care Highlights & Side Effects. Trial Name: NCT04403295 — N/A
Collaborative Specialty Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04403295 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being analyzed in this research project?

"Yes, that is right. The clinicaltrials.gov website has information indicating that this trial is looking for more patients. The trial was first posted on August 24th 2020 and was last updated on January 6th 2022. A total of 220 patients are needed for the study, which will be conducted at 1 site."

Answered by AI
~44 spots leftby Mar 2025