Cardiometabolic SyndromeNCT05192590
Establishing Clinical Utility Evidence for Chronic Disease Management Testing
A study testing Educational Materials and Chronic Disease Management Test (CDMT) in people with Cardiometabolic Syndrome, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiometabolic Syndrome
- What is being tested?
- Educational Materials and Chronic Disease Management Test (CDMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 22 Feb 2023
- 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
- Subjects must meet the following criteria to be enrolled in the study:
- Board-certified physician currently practicing in the following areas:
- Internal medicine
- Family medicine
- Have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years
- Community / non-academic based practice setting
Show all 12Show fewer
- ≥ 40 patients under care weekly
- Commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia
- Practicing in the U.S.
- English-speaking
- Access to the internet
- Informed and voluntarily consented to be in the study
Who cannot join
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Do not voluntarily consent to be in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence for Chronic Disease Management Testing (CDMT): A CPV® RandomizedControlled Trial
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.
Read the detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 300 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.
Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.
- Conditions
- Cardiometabolic Syndrome
- Being tested
- Educational Materials and Chronic Disease Management Test (CDMT)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials and Chronic Disease Management Test (CDMT)Other
Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the CDMT technology. These materials are comprised of a PowerPoint presentation.
Intervention 1 participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT test results only if they select it during the second round of case simulations.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | These providers will complete two rounds of three simulated patient cases (CPVs). Control arm physicians will continue to have access to standard of care diagnostic tools, but not the CDMT test results. |
| Educational Materials and CDMT Test Results (Intervention 1) | Experimental | Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results whether they select it or not. Investigators will compare intervention participants' clinical recommendations to those in the control arm. Receives: Other: Educational Materials and Chronic Disease Management Test (CDMT) |
| Educational Materials and CDMT Test Results when Selected (Intervention 2) | Experimental | Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results only if they select it. Investigators will compare intervention participants' clinical recommendations to those in the control arm. Receives: Other: Educational Materials and Chronic Disease Management Test (CDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPV-measured clinical score difference(drug, procedures, counseling and other)
Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of chronic dyspnea, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.
Measured: 12 months
Test Adoption Rate
Rate of adoption of the CDMT test in Intervention 2 arm participants.
Measured: 12 months
CPV-measured cost difference
Difference in expected cost of care between control and intervention participants. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)
Measured: 12 months
Secondary outcomes (3)
CPV-measured clinical score differences by use case
Difference in the overall, and the diagnostic and treatment quality scores between control and intervention participants. Diagnostic and treatment scores are calculated as the percent correct on CPVs, and the overall score is a average score of the subcategory scores (percent correct). This will be examined for each of the use cases to determine in which case(s) CPV scores most improved.
Measured: 12 months
CPV-measured cost differences by use case
Difference in expected cost of care between control and intervention participants. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.) This will be examined for each of the use cases to determine in which case(s) cost metrics most improved.
Measured: 12 months
CPV-measured baseline variation
Participants completing the simulated cases, or CPVs, receive scores based upon the quality of care they provide. This measure will assess the baseline levels of variation in the care of pain patients among all participants, including by use case types
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start22 Oct 2021
- Primary completion21 Feb 2022
- Study completion22 Feb 2023
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 Cardiometabolic SyndromeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll primary care physicians practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention 1 and intervention 2 arms only will receive educational material about the Aegis test in between these two rounds. Intervention 1 arm participants only will receive the CDMT results whether they select it or not, and Intervention 2 participants will receive the CDMT results only if they select it in the second round of simulated cases
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, David Paculdo, Qure Healthcare, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192590
- Sponsor's protocol ID
- Pro00057790
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peabody JW, Ganesan D, Valdenor C, Paculdo D, Schrecker J, Westerfield C, Heltsley R. Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease. BMC Prim Care. 2023 Apr 15;24(1):100. doi: 10.1186/s12875-023-02042-4.
PubMed 37061690Valdenor C, Ganesan D, Paculdo D, Schrecker J, Heltsley R, Westerfield C, Peabody JW. Clinical Variation in the Treatment Practices for Medication Nonadherence, Drug-Drug Interactions, and Recognition of Disease Progression in Patients with Chronic Cardiometabolic Diseases: A Cross-Sectional Patient Simulation Study among Primary Care Physicians. Int J Clin Pract. 2022 Jul 30;2022:6450641. doi: 10.1155/2022/6450641. eCollection 2022.
PubMed 35989865
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence for Chronic Disease Management Testing (CDMT): A CPV® RandomizedControlled Trial
- ClinicalTrials.gov ID
- NCT05192590
- Acronym / sponsor ID
- Pro00057790
- Conditions
- Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 14 Jan 2022 (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.
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.
Detailed description
The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 300 physicians.
Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.
If physicians are randomized to an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.
Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will enroll primary care physicians practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention 1 and intervention 2 arms only will receive educational material about the Aegis test in between these two rounds. Intervention 1 arm participants only will receive the CDMT results whether they select it or not, and Intervention 2 participants will receive the CDMT results only if they select it in the second round of simulated cases
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –These providers will complete two rounds of three simulated patient cases (CPVs). Control arm physicians will continue to have access to standard of care diagnostic tools, but not the CDMT test results. |
| Educational Materials and CDMT Test Results (Intervention 1) | Experimental | Other: Educational Materials and Chronic Disease Management Test (CDMT)Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results whether they select it or not. Investigators will compare intervention participants' clinical recommendations to those in the control arm. |
| Educational Materials and CDMT Test Results when Selected (Intervention 2) | Experimental | Other: Educational Materials and Chronic Disease Management Test (CDMT)Participants will care for the same set of CPV patients as the control arm, but will be educated on and will receive the CDMT test results only if they select it. Investigators will compare intervention participants' clinical recommendations to those in the control arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must meet the following criteria to be enrolled in the study:
Key exclusion criteria (5 listed)
- Non-English speaking
- Practicing in an academic setting
- Unable to access the internet
- Not practicing in the U.S.
- Do not voluntarily consent to be in the study
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 |
|---|---|---|
| Educational Materials and Chronic Disease Management Test (CDMT)Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the CDMT technology. These materials are comprised of a PowerPoint presentation. Intervention 1 participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT test results only if they select it during the second round of case simulations. | Other | Educational Materials and CDMT Test Results (Intervention 1), Educational Materials and CDMT Test Results when Selected (Intervention 2) |
Primary outcome
CPV-measured clinical score difference(drug, procedures, counseling and other)
Time frame: 12 months
Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of chronic dyspnea, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum from 0 to a high potential score of up to 100 percent in each domain, where higher scores mean better outcomes.
Test Adoption Rate
Time frame: 12 months
Rate of adoption of the CDMT test in Intervention 2 arm participants.
CPV-measured cost difference
Time frame: 12 months
Difference in expected cost of care between control and intervention participants. (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs.)
3 secondary outcomes
CPV-measured clinical score differences by use case
Time frame: 12 months
CPV-measured cost differences by use case
Time frame: 12 months
CPV-measured baseline variation
Time frame: 12 months
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 27 Feb 2026.
- Derived from this study: PubMed 37061690Peabody JW, Ganesan D, Valdenor C, Paculdo D, Schrecker J, Westerfield C, Heltsley R. Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease. BMC Prim Care. 2023 Apr 15;24(1):100. doi: 10.1186/s12875-023-02042-4.
- Derived from this study: PubMed 35989865Valdenor C, Ganesan D, Paculdo D, Schrecker J, Heltsley R, Westerfield C, Peabody JW. Clinical Variation in the Treatment Practices for Medication Nonadherence, Drug-Drug Interactions, and Recognition of Disease Progression in Patients with Chronic Cardiometabolic Diseases: A Cross-Sectional Patient Simulation Study among Primary Care Physicians. Int J Clin Pract. 2022 Jul 30;2022:6450641. doi: 10.1155/2022/6450641. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials and Chronic Disease Management Test (CDMT) in people with Cardiometabolic Syndrome, run by Qure Healthcare, LLC 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 12 inclusion and 5 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 27 Feb 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?
CPV-measured clinical score difference(drug, procedures, counseling and other) (time frame: 12 months). The study lists 3 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 NCT05192590, 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 27 Feb 2026.