Gulf War IllnessNCT04403295
Collaborative Specialty Care for Gulf War Illness
A study testing Collaborative Specialty Care and e-consultation in people with Gulf War Illness, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Collaborative Specialty Care and e-consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- suicidal intent
- previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI
Trial locations and contacts
1 site in 1 country.
United States1 site
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
About this study
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.
Read the 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.
- Conditions
- Gulf War Illness
- Being tested
- Collaborative Specialty Care, e-consultation
- Keywords
- Veteran, Gulf War Illness, implementation, Chronic Pain, health coaching, problem-solving
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Specialty CareBehavioural
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.
e-consultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: e-consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (10)
Brief Pain Inventory - Interference Scale
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.
Measured: 6 months
Patient Health Questionnaire Somatic Symptom Scale - 15
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.
Measured: 6 months
Patient Activation Measure
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.
Measured: 6 months
Satisfaction: Patient Satisfaction Questionnaire
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.
Measured: 6 month
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.
Measured: 9 month
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.
Measured: 9 month
Brief Pain Inventory - Interference Scale
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.
Measured: 9 month
Patient Health Questionnaire Somatic Symptom Scale - 15
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.
Measured: 9 month
Patient Activation Measure
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.
Measured: 9 month
Satisfaction: Patient Satisfaction Questionnaire
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.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start24 Aug 2020
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa Marie McAndrew, PhD, Principal investigator, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJJusteen K Hyde, PhD, Principal investigator, VA Bedford HealthCare System, Bedford, MAScott E. Sherman, MD MPH, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403295
- Sponsor's protocol ID
- IIR 19-469
- Status last verified
- Jul 2026
- First submitted
- 20 May 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34599935Lesnewich 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.
PubMed 37654203
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Specialty Care for Gulf War Illness
- ClinicalTrials.gov ID
- NCT04403295
- Acronym / sponsor ID
- IIR 19-469
- Conditions
- Gulf War Illness
- Keywords
- Veteran, Gulf War Illness, implementation, Chronic Pain, health coaching, problem-solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| collaborative specialty care | Experimental | Behavioral: Collaborative Specialty CareIn 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. |
| e-consultation | Active comparator | Behavioral: e-consultationIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- suicidal intent
- previous evaluation at the WRIISC or participated in our clinical trial for GWVs with GWI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Specialty CareIn 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. | Behavioural | collaborative specialty care |
| e-consultationIn 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. | Behavioural | e-consultation |
Primary outcome
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.
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.
10 secondary outcomes
Brief Pain Inventory - Interference Scale
Time frame: 6 months
Patient Health Questionnaire Somatic Symptom Scale - 15
Time frame: 6 months
Patient Activation Measure
Time frame: 6 months
Satisfaction: Patient Satisfaction Questionnaire
Time frame: 6 month
Roland Morris Disability Scale
Time frame: 9 month
World Health Organization Disability Schedule
Time frame: 9 month
Brief Pain Inventory - Interference Scale
Time frame: 9 month
Patient Health Questionnaire Somatic Symptom Scale - 15
Time frame: 9 month
Patient Activation Measure
Time frame: 9 month
Satisfaction: Patient Satisfaction Questionnaire
Time frame: 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Results publication: PubMed 34599935Schneider 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.
- Results publication: PubMed 37654203Lesnewich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Marie McAndrew, PhD principal investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Justeen K Hyde, PhD principal investigator
VA Bedford HealthCare System, Bedford, MA
Scott E. Sherman, MD MPH principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Specialty Care and e-consultation in people with Gulf War Illness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403295, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.