Collaborative Specialty Care for Gulf War Illness

March 5, 2026 updated by: VA Office of Research and Development
Gulf War Veterans (GWVs) with Gulf War Illness (GWI) do not receive the care they should in the Veterans Affairs (VA). The investigators' data show 70% of GWVs with Gulf War Illness (GWI) do not receive treatment recommendations for their GWI and 78% are NOT very satisfied with their care. The quality of care GWVs receive must improve. VA and DoD have invested hundreds of millions of dollars to develop new treatments for GWVs, without effective delivery methods GWVs will not benefit. This study will be the first study to examine the best model of care to deliver treatments to GWVs with GWI. Determining the best model of care to translate research into practice is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There is a quality chasm between the care Gulf War Veterans (GWVs) should receive and the care they do receive. The investigators' data show 70% of GWVs with Gulf War Illness (GWI) do not receive treatment recommendations for their GWI and 78% are NOT very satisfied with their care. Reducing this quality chasm is essential. The VA and DoD have invested hundreds of millions of dollars to develop new treatments, including the second largest clinical trial for GWVs which is finding health coaching and problem-solving treatment both reduce the disability of GWI. Without effective models of healthcare to implement these treatments, GWVs will not benefit. In the current model of care, GWVs receive care locally through VA's primary care patient aligned care teams (PACTs). The VA War Related Illness and Injury Study Center (WRIISC) supports the current model of care by increasing local knowledge of the skills and treatments needed to manage GWI through national education efforts and electronic consultation (e-consultation) on difficult cases. The WRIISC and other stakeholders are currently questioning whether improving local knowledge of skills and treatments for GWI is enough to address the quality chasm, or if GWI is too complex to be treated in primary care without additional support from specialists in GWI. A potentially useful model of care for GWI is collaborative specialty care where specialists work with PACTs to synergistically treat patients. The local PACT is the lead of the team with the specialist providing some direct care to the patient (through tele-health) and also consulting with the PACT about other aspects of care. Collaborative specialty care is effective for other complex conditions (e.g., depression) with over 40 studies documenting its efficacy. The goal of this proposal is to conduct a hybrid type 1 randomized effectiveness/implementation trial for GWVs with GWI (n=220). The primary aim is to determine the effectiveness of tele-CSC as compared to e-consultation. In tele-CSC, the investigators' specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the PACT make monthly optimization of analgesics. In e-consultation the specialty provider team will make a onetime recommendation to the PACT that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization. The secondary aim is to understand implementation outcomes. This information will be used to guide a future randomized (by VISN) multi-site implementation study. Throughout, an advisory committee of operations partners will be convened to ensure that the results of the study are able to directly and immediately improve care. Determining the best model of care to translate research into practice for GWVs with GWI is a key goal of the VA Gulf War Strategic Plan and a specific aim of this Request for Applications.

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • deployed to Operation Desert Shield/Storm
  • meets Kansas City (Steele) definition of GWI (which excludes conditions that may account for GWI)
  • rates their activity limitations from pain at least 3 on a 0 to 10 point scale
  • has a VA primary care provider

Exclusion Criteria:

  • suicidal intent
  • previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: collaborative specialty care
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.
Behavioral: Collaborative Specialty Care
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.
Active Comparator: e-consultation
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.
Behavioral: e-consultation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Scale
Time Frame: 6 months
Pain disability will be assessed with the RMDS a 24 item scale of disability from pain. The RMDS is a core outcome measure for patients with chronic pain. A change of 2-3 points is considered clinically significant. Pain is present in 99% of GWVs with GWI and previous collaborative care trials in the VA have used this measure. Scores range from 0-24 with higher scores = greater disability.
6 months
World Health Organization Disability Schedule
Time Frame: 6 months
The WHO-DAS 2.0 measures disability which is due to physical and mental health conditions. The WHO-DAS 2.0 is a 40 item measure that assesses 6 life tasks. The composite score will be used as the dependent variable. The items of the WHO-DAS have a factor loading on composite score of 0.82 to 0.98. The WHO-DAS was the primary outcome in our previous trial of problem-solving treatment and captures all over health disability. Scores range from 0-100 with higher scores equaling greater disability.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory - Interference Scale
Time Frame: 6 months
The 7 item scale measures pain interference on mood, physical activity, social activity and other life activities. A one-point change is clinically significant. Scores range from 0-10 with higher scores equaling greater pain interference.
6 months
Patient Health Questionnaire Somatic Symptom Scale - 15
Time Frame: 6 months
The PHQ-15 captures somatic symptoms. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change. Scores range from 0-30 and higher scores are greater symptom severity.
6 months
Patient Activation Measure
Time Frame: 6 months
The PAM is a 13 item self-report measure of the patient's active engagement in self-management their health. The PAM is reliable and valid. Scores range from 0-100 with higher scores indicating greater activation.
6 months
Satisfaction: Patient Satisfaction Questionnaire
Time Frame: 6 month
The PSQ-III is a 50-item self-report measure with 7 subscales reliability with ranges from .77-.89. The investigators will use the composite score. Score range from 0-100 with higher scores indicating greater satisfaction.
6 month
Roland Morris Disability Scale
Time Frame: 9 month
Pain disability will be assessed with the RMDS a 24 item scale of disability from pain. The RMDS is a core outcome measure for patients with chronic pain. A change of 2-3 points is considered clinically significant. Pain is present in 99% of GWVs with GWI and previous collaborative care trials in the VA have used this measure. Scores range from 0-24 with higher scores = greater disability.
9 month
World Health Organization Disability Schedule
Time Frame: 9 month
The WHO-DAS 2.0 measures disability which is due to physical and mental health conditions. The WHO-DAS 2.0 is a 40 item measure that assesses 6 life tasks. The composite score will be used as the dependent variable. The items of the WHO-DAS have a factor loading on composite score of 0.82 to 0.98. The WHO-DAS was the primary outcome in our previous trial of problem-solving treatment and captures all over health disability. Scores range from 0-100 with higher scores equaling greater disability.
9 month
Brief Pain Inventory - Interference Scale
Time Frame: 9 month
The 7 item scale measures pain interference on mood, physical activity, social activity and other life activities. A one-point change is clinically significant. Scores range from 0-10 with higher scores equaling greater pain interference.
9 month
Patient Health Questionnaire Somatic Symptom Scale - 15
Time Frame: 9 month
The PHQ-15 captures somatic symptoms. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change. Scores range from 0-30 and higher scores are greater symptom severity.
9 month
Patient Activation Measure
Time Frame: 9 month
The PAM is a 13 item self-report measure of the patient's active engagement in self-management their health. The PAM is reliable and valid. Scores range from 0-100 with higher scores indicating greater activation.
9 month
Satisfaction: Patient Satisfaction Questionnaire
Time Frame: 9 month
The PSQ-III is a 50-item self-report measure with 7 subscales reliability with ranges from .77-.89. The investigators will use the composite score. Score range from 0-100 with higher scores indicating greater satisfaction.
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Lisa Marie McAndrew, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  • Principal Investigator: Justeen K Hyde, PhD, VA Bedford HealthCare System, Bedford, MA
  • Principal Investigator: Scott E. Sherman, MD MPH, VA NY Harbor Healthcare System, New York, NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

March 2, 2026

Study Completion (Estimated)

May 29, 2026

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 19-469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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