| NCT ID | NCT05787379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Post-Acute COVID-19 Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 348 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 348 participants in total. It began in 2025-01-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions such as Long-COVID. Part 1 of the study will optimize and test if a Concordant Care training improves VA clinicians' engagement in recommended practices to provide Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with Long-COVID. This study will adapt and refine Concordant Care training for Long-COVID. Part 2 of this study will determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care and will explore the effectiveness of Concordant Care on care outcomes including satisfaction, adherence to care, \& disability for Veterans with Long-COVID. Veterans treated by clinicians receiving Concordant Care training will report their clinician more frequently engaged in recommended conversations (i.e., ask about Long-COVID, validate experience with Long-COVID, create a shared understanding and action plan), and Veterans will perceive greater shared understanding of Long-COVID with their clinicians than Veterans treated by clinicians in the control arm.
Eligibility Criteria
Inclusion Criteria: * Part 1 and Part 2, English-speaking VA primary care providers will be included. * Part 1, Veterans who self-identify as having Long-COVID will be included. * Part 2, Veterans who meet criteria for Long-COVID assessed with modified DePaul Symptom Questionnaire version 2 will be included; * Part 2, Veterans must also have a scheduled appointment with one of the participating clinicians within one to six months of the clinician being consented. Exclusion Criteria: * Part 1 and Part 2, clinicians who have already taken Concordant Care training will be excluded. * Part 1, Veterans will be excluded if they are not receiving care in the VA. * Part 2, Veterans will be excluded if they were in the Intensive Care Unit (ICU) for COVID-19.
Contact & Investigator
Lisa Marie McAndrew, PhD
PRINCIPAL INVESTIGATOR
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Frequently Asked Questions
Who can join the NCT05787379 clinical trial?
This trial is open to participants of all sexes, studying Post-Acute COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05787379 currently recruiting?
Yes, NCT05787379 is actively recruiting participants. Contact the research team at Lisa.Mcandrew@va.gov for enrollment information.
Where is the NCT05787379 trial being conducted?
This trial is being conducted at East Orange, United States.
Who is sponsoring the NCT05787379 clinical trial?
NCT05787379 is sponsored by VA Office of Research and Development. The principal investigator is Lisa Marie McAndrew, PhD at East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ. The trial plans to enroll 348 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.