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

Primary Purpose

Cardiovascular Diseases, Medical Device, Primary Health Care

Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
AI-assisted Clinical Assistant PMcardio
Sponsored by
Powerful Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiovascular Diseases, Medical Device, Primary Health Care, Diagnostic Tool, Artificial Inteligence, A.I. Clinical Assistant, Powerful Medical, PMcardio, Electrocardiogram, ECG, ECG Diagnostic

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MUZMED s.r.o.
  • MAR-BID s.r.o.
  • SIMAMED, s.r.o.
  • SollarMED, s.r.o.
  • NÁGEL, s.r.o.
  • MEDIFARMA s.r.o.
  • Promedicum, s.r.o.
  • GP Humenné, s.r.o.
  • LPSo spol. s r.o.
  • MED - AID s.r.o.
  • MUDr. Peter Križalkovič
  • MUDr. Ildikó Papáčková
  • BELLIS-med s.r.o.
  • MEDIKONTAKT, s.r.o.
  • IRS - Medicínska činnosť s.r.o.
  • MUCOMED s.r.o.
  • MUDr. Ján Telepovský
  • SANABITUR, s.r.o.
  • Anahata s.r.o.
  • FONTHIS, s.r.o.
  • MUDr. Mária Schmidtová, s.r.o.
  • Vaša ambulancia, s. r. o.
  • MUDr. Ondrej Gajdoš
  • Medic I+H s.r.o.
  • JANMED, s.r.o.
  • Cardio Clinic s.r.o.
  • G.Praktik s.r.o.
  • HODOSI-MED s.r.o
  • Tamice,s.r.o.
  • TOMICI s.r.o.
  • Timimed s. r. o.
  • VERKIAD s.r.o.
  • VALETUDO s.r.o.
  • RODMED s.r.o.
  • LEK - NO, s.r.o.
  • Duo medical s.r.o.
  • PALMED, s.r.o.
  • MEDIPRAX s.r.o
  • PULSE medicine, s.r.o
  • GP - PRAKTIK, s.r.o.
  • KNG s.r.o.
  • MDPRAK, s.r.o.
  • RM - MEDICAL s.r.o.
  • CorMedicus s.r.o.
  • Jklinik s.r.o
  • PT Care s.r.o.
  • MUDr. Boris Piteľ
  • MEDICATEK s.r.o.
  • VINOVA Group s.r.o.
  • GPII Medical s.r.o.
  • MUDr. Peter MARKO, s.r.o.
  • Resutík s.r.o.
  • MUDr. Viera Čuchranová
  • JOMED, spol. s r.o.
  • AVK MEDIC, s.r.o.
  • MUDr. Orság Juraj, s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Intervention Group

Control Group

Arm Description

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

The usual standard of care, with NO AI-based diagnosis or treatment recommendation available.

Outcomes

Primary Outcome Measures

Time to first cardiovascular-related consultation
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
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 hospitalization
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
Time to first cardiovascular-related drug prescription
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

Cost-effectiveness ratio and effect on cost savings
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
The duration of time that the operating system of the application has been working and available in a reliable operating manner.
Reliability and safety of the PMcardio measured by system failures
The Number of failures by PMcardio application that caused the system to end abnormally.
General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).
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.

Full Information

First Posted
December 13, 2021
Last Updated
July 29, 2022
Sponsor
Powerful Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05329246
Brief Title
Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
Acronym
PMCARDIO-PT1
Official Title
Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Powerful Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Medical Device, Primary Health Care, Electrocardiogram, Dyspnea, Chest Pain, Syncope, Breath Shortness, General Practitioner
Keywords
Cardiovascular Diseases, Medical Device, Primary Health Care, Diagnostic Tool, Artificial Inteligence, A.I. Clinical Assistant, Powerful Medical, PMcardio, Electrocardiogram, ECG, ECG Diagnostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
836 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The usual standard of care, with NO AI-based diagnosis or treatment recommendation available.
Intervention Type
Device
Intervention Name(s)
AI-assisted Clinical Assistant PMcardio
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first cardiovascular-related consultation
Description
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 Frame
From randomization to enrollment period completion (up to 6 months)
Title
Time to first cardiovascular-related diagnostic testing
Description
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 Frame
From randomization to to enrollment period completion (up to 6 months)
Title
Time to first cardiovascular-related hospitalization
Description
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
Time Frame
From randomization to to enrollment period completion (up to 6 months)
Title
Time to first cardiovascular-related drug prescription
Description
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 Frame
From randomization to to enrollment period completion (up to 6 months)
Secondary Outcome Measure Information:
Title
Cost-effectiveness ratio and effect on cost savings
Description
Cost-effectiveness ratio and projected effect on cost savings resulting from PMcardio remote specialist consultations measured based on Health Insurance data
Time Frame
1 year
Title
Reliability and safety of the PMcardio measured by system up-time
Description
The duration of time that the operating system of the application has been working and available in a reliable operating manner.
Time Frame
From the very first participants randomization to total follow-up time (up to 6 months)
Title
Reliability and safety of the PMcardio measured by system failures
Description
The Number of failures by PMcardio application that caused the system to end abnormally.
Time Frame
From the very first participants randomization to total follow-up time (up to 6 months)
Title
General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).
Description
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.
Time Frame
From randomization to study completion (up to 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hatala, PhD
Organizational Affiliation
Chief Scientist and Founder
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUZMED s.r.o.
City
Bardejov
Country
Slovakia
Facility Name
MAR-BID s.r.o.
City
Bidovce
Country
Slovakia
Facility Name
SIMAMED, s.r.o.
City
Borský Mikuláš
Country
Slovakia
Facility Name
SollarMED, s.r.o.
City
Bratislava
Country
Slovakia
Facility Name
NÁGEL, s.r.o.
City
Búč
Country
Slovakia
Facility Name
MEDIFARMA s.r.o.
City
Dolný Kubín
Country
Slovakia
Facility Name
Promedicum, s.r.o.
City
Hanušovce nad Topľou
Country
Slovakia
Facility Name
GP Humenné, s.r.o.
City
Humenné
Country
Slovakia
Facility Name
LPSo spol. s r.o.
City
Humenné
Country
Slovakia
Facility Name
MED - AID s.r.o.
City
Humenné
Country
Slovakia
Facility Name
MUDr. Peter Križalkovič
City
Hurbanovo
Country
Slovakia
Facility Name
MUDr. Ildikó Papáčková
City
Kolárovo
Country
Slovakia
Facility Name
BELLIS-med s.r.o.
City
Komárno
Country
Slovakia
Facility Name
MEDIKONTAKT, s.r.o.
City
Komárno
Country
Slovakia
Facility Name
IRS - Medicínska činnosť s.r.o.
City
Košice
Country
Slovakia
Facility Name
MUCOMED s.r.o.
City
Košice
Country
Slovakia
Facility Name
MUDr. Ján Telepovský
City
Košice
Country
Slovakia
Facility Name
SANABITUR, s.r.o.
City
Križovany nad Dudváhom
Country
Slovakia
Facility Name
Anahata s.r.o.
City
Lenartovce
Country
Slovakia
Facility Name
FONTHIS, s.r.o.
City
Levice
Country
Slovakia
Facility Name
MUDr. Mária Schmidtová, s.r.o.
City
Martin
Country
Slovakia
Facility Name
Vaša ambulancia, s. r. o.
City
Martin
Country
Slovakia
Facility Name
MUDr. Ondrej Gajdoš
City
Medzev
Country
Slovakia
Facility Name
Medic I+H s.r.o.
City
Medzilaborce
Country
Slovakia
Facility Name
JANMED, s.r.o.
City
Michalovce
Country
Slovakia
Facility Name
Cardio Clinic s.r.o.
City
Moldava nad Bodvou
Country
Slovakia
Facility Name
G.Praktik s.r.o.
City
Moldava nad Bodvou
Country
Slovakia
Facility Name
HODOSI-MED s.r.o
City
Moldava nad Bodvou
Country
Slovakia
Facility Name
Tamice,s.r.o.
City
Moldava nad Bodvou
Country
Slovakia
Facility Name
TOMICI s.r.o.
City
Nesvady
Country
Slovakia
Facility Name
Timimed s. r. o.
City
Nitra
Country
Slovakia
Facility Name
VERKIAD s.r.o.
City
Nitra
Country
Slovakia
Facility Name
VALETUDO s.r.o.
City
Nitrianske Hrnčiarovce
Country
Slovakia
Facility Name
RODMED s.r.o.
City
Nové Zámky
Country
Slovakia
Facility Name
LEK - NO, s.r.o.
City
Námestovo
Country
Slovakia
Facility Name
Duo medical s.r.o.
City
Pezinok
Country
Slovakia
Facility Name
PALMED, s.r.o.
City
Podolínec
Country
Slovakia
Facility Name
MEDIPRAX s.r.o
City
Poprad
Country
Slovakia
Facility Name
PULSE medicine, s.r.o
City
Poprad
Country
Slovakia
Facility Name
GP - PRAKTIK, s.r.o.
City
Prešov
Country
Slovakia
Facility Name
KNG s.r.o.
City
Prešov
Country
Slovakia
Facility Name
MDPRAK, s.r.o.
City
Prešov
Country
Slovakia
Facility Name
RM - MEDICAL s.r.o.
City
Prievidza
Country
Slovakia
Facility Name
CorMedicus s.r.o.
City
Ruskov
Country
Slovakia
Facility Name
Jklinik s.r.o
City
Ružomberok
Country
Slovakia
Facility Name
PT Care s.r.o.
City
Spišský Hrušov
Country
Slovakia
Facility Name
MUDr. Boris Piteľ
City
Stakčín
Country
Slovakia
Facility Name
MEDICATEK s.r.o.
City
Starý Tekov
Country
Slovakia
Facility Name
VINOVA Group s.r.o.
City
Strekov
Country
Slovakia
Facility Name
GPII Medical s.r.o.
City
Tekovské Lužany
Country
Slovakia
Facility Name
MUDr. Peter MARKO, s.r.o.
City
Veľká Lomnica
Country
Slovakia
Facility Name
Resutík s.r.o.
City
Veľký Krtíš
Country
Slovakia
Facility Name
MUDr. Viera Čuchranová
City
Vinné
Country
Slovakia
Facility Name
JOMED, spol. s r.o.
City
Vranov nad Topľou
Country
Slovakia
Facility Name
AVK MEDIC, s.r.o.
City
Štúrovo
Country
Slovakia
Facility Name
MUDr. Orság Juraj, s.r.o.
City
Želiezovce
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.powerfulmedical.com/
Description
PMcardio Landing Page

Learn more about this trial

Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

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