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Validation of PMcardio AI-assisted Clinical Assistant in Primary Care (PMCARDIO-PT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05329246
Recruitment Status : Completed
First Posted : April 14, 2022
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Powerful Medical

Brief Summary:
This study aimed to analyze and investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to evaluate time savings and cost saving implications of increased availability of specialised care at the primary care level.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Medical Device Primary Health Care Electrocardiogram Dyspnea Chest Pain Syncope Breath Shortness General Practitioner Device: AI-assisted Clinical Assistant PMcardio Not Applicable

Detailed Description:
It is a multi-centric, physician-driven, patient-blinded randomized controlled trial of patients presenting to the general practitioner with typical cardiovascular symptoms (specifically, chest pain, syncope, palpitations, or shortness of breath) constituting an electrocardiogram examination. Eligible patients will be enrolled at the participating general practitioner clinics and managed either through the PMcardio platform with AI-assisted diagnostics, patient management recommendations or usual standard of care throughout their initial visit. Enrolled participants will be followed-up through health insurance billing codes and there will be no personal follow-up visits required. The aim of the study is to investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to assess time savings and cost saving implications of increased availability of specialised care at the primary care level.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 836 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial
Actual Study Start Date : November 22, 2021
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Experimental Intervention Group
AI-assisted interpretation of the ECG including the predicted ECG diagnoses, disease-specific anamnestic questions, and patient management recommendations for referral to secondary care, including suggestions for procedures and further diagnostic tests
Device: AI-assisted Clinical Assistant PMcardio
PMcardio is an AI-powered clinical assistant in the form of a mobile application empowering non-cardiologist healthcare workers with advanced cardiovascular diagnostic capabilities, recommending patient-specific suggestions for referral and facilitating remote consultations with specialized cardiologists.

No Intervention: Control Group
The usual standard of care, with NO AI-based diagnosis or treatment recommendation available.



Primary Outcome Measures :
  1. Time to first cardiovascular-related consultation [ Time Frame: From randomization to enrollment period completion (up to 6 months) ]
    Time from randomization to the first cardiovascular-related consultation or a follow-up visit at specialized physician in patients, where specialized consultation is indicated based on the general practitioner recommendation after using PMcardio application. The measurement will be assessed from the data received from the health insurance provider.

  2. Time to first cardiovascular-related diagnostic testing [ Time Frame: From randomization to to enrollment period completion (up to 6 months) ]
    Time from randomization to the first cardiovascular-related further diagnostic testing (laboratory parameters, ECG Holter, echocardiography).The measurement will be assessed from the data received from the health insurance provider

  3. Time to first cardiovascular-related hospitalization [ Time Frame: From randomization to to enrollment period completion (up to 6 months) ]
    Time from randomization to the first hospitalization in patients, where hospitalization is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider

  4. Time to first cardiovascular-related drug prescription [ Time Frame: From randomization to to enrollment period completion (up to 6 months) ]
    Time from randomization to the first cardiovascular-related drug prescription in patients, where drug prescription is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider


Secondary Outcome Measures :
  1. Cost-effectiveness ratio and effect on cost savings [ Time Frame: 1 year ]
    Cost-effectiveness ratio and projected effect on cost savings resulting from PMcardio remote specialist consultations measured based on Health Insurance data

  2. Reliability and safety of the PMcardio measured by system up-time [ Time Frame: From the very first participants randomization to total follow-up time (up to 6 months) ]
    The duration of time that the operating system of the application has been working and available in a reliable operating manner.

  3. Reliability and safety of the PMcardio measured by system failures [ Time Frame: From the very first participants randomization to total follow-up time (up to 6 months) ]
    The Number of failures by PMcardio application that caused the system to end abnormally.

  4. General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale). [ Time Frame: From randomization to study completion (up to 1 year) ]
    The Client Satisfaction Questionnaire (CSQ-8 scale) measures general satisfaction of participating general practitioners with the functionality of the application at the end of the enrollment period. Possible scores range from 8 to 32, with higher scores indicating higher satisfaction with the application.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female aged 55 years or above.
  • Participant is willing and able to give informed consent for participation in the study.
  • Presenting to the GP with ANY of the following cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath.
  • Patients insured by Dôvera ZP or Union ZP health insurance providers.

Exclusion Criteria:

  • Reason for doing the ECG at the GP clinic is a routine examination or pre-operative assessment.
  • Participant does not present with cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath.
  • Participant is already included in the study due to a prior GP visit throughout the trial period (e.g., participant comes for a second visit to GP clinic due to cardiovascular symptoms).
  • Patients insured by VšZP health insurance provider
  • Female participants who are pregnant, lactating or planning pregnancy during the study.
  • Any other significant comorbidity, disease, or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05329246


Locations
Show Show 56 study locations
Sponsors and Collaborators
Powerful Medical
Investigators
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Principal Investigator: Robert Hatala, PhD Chief Scientist and Founder
Additional Information:
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Responsible Party: Powerful Medical
ClinicalTrials.gov Identifier: NCT05329246    
Other Study ID Numbers: 202106001
CIV-21-09-037810 ( Other Identifier: Clinical Investigation ID )
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Powerful Medical:
Cardiovascular Diseases
Medical Device
Primary Health Care
Diagnostic Tool
Artificial Inteligence
A.I. Clinical Assistant
Powerful Medical
PMcardio
Electrocardiogram
ECG
ECG Diagnostic
Additional relevant MeSH terms:
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Dyspnea
Syncope
Cardiovascular Diseases
Chest Pain
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Pain
Neurologic Manifestations
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Nervous System Diseases