Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Medical Device; Primary Health Care; Electrocardiogram; Dyspnea; Chest Pain; Breath Shortness; General Practitioner; Syncope

• Registration Number: NCT05329246
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2021-11-22
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 836

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first cardiovascular-related consultation	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.
Time to first cardiovascular-related diagnostic testing	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
Time to first cardiovascular-related drug prescription	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
Time to first cardiovascular-related hospitalization	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

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness ratio and effect on cost savings	1 year	Cost-effectiveness ratio and projected effect on cost savings resulting from PMcardio remote specialist consultations measured based on Health Insurance data
Reliability and safety of the PMcardio measured by system up-time	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.
General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).	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.
Reliability and safety of the PMcardio measured by system failures	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.

Trial Locations

Locations (56)

MUZMED s.r.o.; 🇸🇰 Bardejov, Slovakia

MAR-BID s.r.o.; 🇸🇰 Bidovce, Slovakia

SIMAMED, s.r.o.; 🇸🇰 Borský Mikuláš, Slovakia

SollarMED, s.r.o.; 🇸🇰 Bratislava, Slovakia

NÁGEL, s.r.o.; 🇸🇰 Búč, Slovakia

MEDIFARMA s.r.o.; 🇸🇰 Dolný Kubín, Slovakia

Promedicum, s.r.o.; 🇸🇰 Hanušovce nad Topľou, Slovakia

GP Humenné, s.r.o.; 🇸🇰 Humenné, Slovakia

LPSo spol. s r.o.; 🇸🇰 Humenné, Slovakia

MED - AID s.r.o.; 🇸🇰 Humenné, Slovakia

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