Care for Veterans Post-COVID-19

December 17, 2025 updated by: VA Office of Research and Development

Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a two-part study. 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. 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. Concordant Care will be adapted through interviews and focus groups with Veterans with Long-COVID (estimated n=9) and primary care providers (estimated n=21). Feedback from the participants will help refine and test Concordant Care training. 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. Part 2 will be a randomized parallel cluster trial with primary care clinicians (n=60) separated into a Concordant Care training group and an education packet control group. Veterans (n=240) who have an upcoming appointment with their primary care provider who is a participant in the study will be recruited. The Veterans will be assessed at baseline before their appointment and approximately 3-months later after their appointment. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Recruiting
        • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
        • Principal Investigator:
          • Lisa Marie McAndrew, PhD
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Providers receiving Long-COVID Concordant Care Training
Providers randomized to this arm will receive concordant care training.
Behavioral: Concordant Care Training
Concordant Care training has four components. 1. Clinicians will complete ~3 hours of online, asynchronous training that will teach them practices including validate Veterans' experiences with Long-COVID, develop shared understanding with patients about Long-COVID, and develop patient-centered action plans. Clinicians will be provided with handouts, case examples, video demonstrations, and practice exercises to help them integrate these practices into care. 2. Tele-mentoring groups will be offered ~bi-weekly and be open to all clinician participant in the Concordant Training arm. Content will include review of specific cases, didactics on specific Concordant Care practices, role-play exercises, and review of session recordings. At least two sessions are required. 3. Clinician Pocket Card that serves as a reminder of the Concordant Care process. 4. An electronic prompt will be sent to enrolled Veterans encouraging them to speak with their clinician about their Long-COVID concerns.
Active Comparator: Providers receiving Education Packet Training
Providers randomized to this arm will receive education packet training.
Behavioral: Education Packet Training
Clinicians randomized to the control arm will receive a comprehensive information packet with the latest understanding of Long-COVID. Clinicians will also be provided a packet directing them to relevant VA trainings for Long-COVID. Whole Health trainings which focus on wholistic integrated approaches to care will be highlighted. Whole Health is important for all Veterans, and it is thought to be particularly relevant for poorly understood conditions that don't easily fit in traditional medical model.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concordant Care Practice Change
Time Frame: Baseline and 3-months
Concordant Care practices will be measured with the 11-item measure that asks the patient if the clinician talked with them about multiple dimensions of their understanding of the health condition (i.e., cause, consequence, treatment). Participants answer yes or no to each question. Scores range from 0 to 11 with a higher score = more Concordant Care practices.
Baseline and 3-months
Concordance of Illness Perceptions Questionnaire Change
Time Frame: Baseline and 3-months
Shared Understanding will be captured with the concordance of illness perceptions questionnaire, a 6-item validated measure of shared understanding of the 5 components of illness perception between patients and clinicians. Veterans respond on a 5-point Likert scale. Scores range from 6 to 30 with higher scores = greater concordant understanding.
Baseline and 3-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Questionnaire (PSQ-III)
Time Frame: Baseline and 3-months
The 18-item PSQ measures patient satisfaction in health care services and has been used specifically to assess patient satisfaction of VA healthcare services. Response options are 1-5 with 1=strongly agree and 5=strongly disagree. Scores range from 18 to 90 with higher scores = greater satisfaction with medical care.
Baseline and 3-months
Medical Outcomes Survey Adherence Scale
Time Frame: Baseline and 3-months
The Medical Outcomes Survey Adherence 5-item scale captures Veterans adherence to primary care clinician's recommendations. Scores range from 6 to 30 with greater scores = better adherence.
Baseline and 3-months
Veterans Rand (VR-12)
Time Frame: Baseline and 3-months
Veterans Rand 12-item Health Survey (VR-12). The VR-12 is a well-validated quality of life measure that assesses multiple domains of physical and mental health functioning. Scores range from 0 to 100 with higher scores = less disability.
Baseline and 3-months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Marie McAndrew, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDR 23-001

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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