Collaborative Specialty Care for Gulf War Illness

NCT04403295 | Active Not Recruiting DMC

• 1 other identifier: IIR 19-469
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gulf War Illness

Keywords

Veteran; Gulf War Illness; implementation; Chronic Pain; health coaching; problem-solving

Outcome Measures

Primary Outcomes (2)

• Roland Morris Disability Scale

  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

  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 Outcomes (10)

• Brief Pain Inventory - Interference Scale

  6 months

• Patient Health Questionnaire Somatic Symptom Scale - 15

  6 months

• Patient Activation Measure

  6 months

• Satisfaction: Patient Satisfaction Questionnaire

  6 month

• Roland Morris Disability Scale

  9 month

Study Arms (2)

collaborative specialty care

EXPERIMENTAL

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

e-consultation

ACTIVE COMPARATOR

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

Interventions

Collaborative Specialty Care BEHAVIORAL

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.

collaborative specialty care

e-consultation BEHAVIORAL

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.

e-consultation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

Location

Related Publications (2)

• Schneider AH, Bair MJ, Helmer DA, Hyde J, Litke D, Lu SE, Rogers ES, Sherman SE, Sotolongo A, Anastasides N, Sullivan N, Graff F, McAndrew LM. Protocol for a type 1 hybrid effectiveness/implementation clinical trial of collaborative specialty care for Veterans with Gulf War Illness. Life Sci. 2022 Mar 1;292:120004. doi: 10.1016/j.lfs.2021.120004. Epub 2021 Sep 29.

  PMID: 34599935 RESULT

• Lesnewich LM, Hyde JK, McFarlin ML, Bolton RE, Bayley PJ, Chandler HK, Helmer DA, Phillips LA, Reinhard MJ, Santos SL, Stewart RS, McAndrew LM. 'She thought the same way I that I thought:' a qualitative study of patient-provider concordance among Gulf War Veterans with Gulf War Illness. Psychol Health. 2025 Apr;40(4):616-634. doi: 10.1080/08870446.2023.2248481. Epub 2023 Sep 1.

  PMID: 37654203 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study coordinator conducting the randomization and study providers will not be blinded. Other staff and investigators (including the Principal Investigator) will be blind to study assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: In collaborative specialty 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

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: August 24, 2020
• Primary Completion: March 2, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)