Post-Acute COVID-19 SyndromeNCT05787379
Care for Veterans Post-COVID-19
A study testing Concordant Care Training and Education Packet Training in people with Post-Acute COVID-19 Syndrome, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- Concordant Care Training and Education Packet Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
Amanda L Matteson, (973) 676-1000 ext. 203580, amanda.matteson@va.gov
Lisa Marie McAndrew, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Acute COVID-19 Syndrome
- Being tested
- Concordant Care Training, Education Packet Training
- Keywords
- training, COVID-19, post-acute sequelae of COVID infection
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concordant Care TrainingBehavioural
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.
Education Packet TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Providers receiving Long-COVID Concordant Care Training | Experimental | Providers randomized to this arm will receive concordant care training. Receives: Behavioral: Concordant Care Training |
| Providers receiving Education Packet Training | Active comparator | Providers randomized to this arm will receive education packet training. Receives: Behavioral: Education Packet Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordant Care Practice Change
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.
Measured: Baseline and 3-months
Concordance of Illness Perceptions Questionnaire Change
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.
Measured: Baseline and 3-months
Secondary outcomes (3)
Patient Satisfaction Questionnaire (PSQ-III)
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.
Measured: Baseline and 3-months
Medical Outcomes Survey Adherence Scale
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.
Measured: Baseline and 3-months
Veterans Rand (VR-12)
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.
Measured: Baseline and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jan 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 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. The training involves four components: completion of approx. 3 hours of online, asynchronous training; attendance to at least two tele-mentoring sessions to review specific cases, didactics, role-play exercises, and session recordings; obtaining a clinician pocket care with reminders of Concordant Care process; and being prompted by a Veteran patient to talk about their concerns with Long-COVID.
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
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, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787379
- Sponsor's protocol ID
- SDR 23-001
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans
- ClinicalTrials.gov ID
- NCT05787379
- Acronym / sponsor ID
- SDR 23-001
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- training, COVID-19, post-acute sequelae of COVID infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Mar 2023 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The 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. The training involves four components: completion of approx. 3 hours of online, asynchronous training; attendance to at least two tele-mentoring sessions to review specific cases, didactics, role-play exercises, and session recordings; obtaining a clinician pocket care with reminders of Concordant Care process; and being prompted by a Veteran patient to talk about their concerns with Long-COVID.
| Arm | Type | Receives |
|---|---|---|
| Providers receiving Long-COVID Concordant Care Training | Experimental | Behavioral: Concordant Care TrainingProviders randomized to this arm will receive concordant care training. |
| Providers receiving Education Packet Training | Active comparator | Behavioral: Education Packet TrainingProviders randomized to this arm will receive education packet training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Concordant Care TrainingConcordant 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. | Behavioural | Providers receiving Long-COVID Concordant Care Training |
| Education Packet TrainingClinicians 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. | Behavioural | Providers receiving Education Packet Training |
Primary outcome
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.
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.
3 secondary outcomes
Patient Satisfaction Questionnaire (PSQ-III)
Time frame: Baseline and 3-months
Medical Outcomes Survey Adherence Scale
Time frame: Baseline and 3-months
Veterans Rand (VR-12)
Time frame: Baseline and 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Lisa Marie McAndrew, PhD principal investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concordant Care Training and Education Packet Training in people with Post-Acute COVID-19 Syndrome, 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 3 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M McAndrew, PhD ((862) 400-3317, Lisa.Mcandrew@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordant Care Practice Change (time frame: Baseline and 3-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?
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 24 Dec 2025.