Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
PMCARDIO-PT1
Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial
2 other identifiers
interventional
836
1 country
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Nov 2021
Shorter than P25 for not_applicable cardiovascular-diseases
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2021
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 2, 2022
July 1, 2022
7 months
December 13, 2021
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
From randomization to enrollment period completion (up to 6 months)
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
From randomization to to enrollment period completion (up to 6 months)
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
From randomization to to enrollment period completion (up to 6 months)
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
From randomization to to enrollment period completion (up to 6 months)
Secondary Outcomes (4)
Cost-effectiveness ratio and effect on cost savings
1 year
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)
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)
General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).
From randomization to study completion (up to 1 year)
Study Arms (2)
Experimental Intervention Group
EXPERIMENTALAI-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
Control Group
NO INTERVENTIONThe usual standard of care, with NO AI-based diagnosis or treatment recommendation available.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Powerful Medicallead
Study Sites (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
MUDr. Peter Križalkovič
Hurbanovo, Slovakia
MUDr. Ildikó Papáčková
Kolárovo, Slovakia
BELLIS-med s.r.o.
Komárno, Slovakia
MEDIKONTAKT, s.r.o.
Komárno, Slovakia
IRS - Medicínska činnosť s.r.o.
Košice, Slovakia
MUCOMED s.r.o.
Košice, Slovakia
MUDr. Ján Telepovský
Košice, Slovakia
SANABITUR, s.r.o.
Križovany Nad Dudváhom, Slovakia
Anahata s.r.o.
Lenartovce, Slovakia
FONTHIS, s.r.o.
Levice, Slovakia
MUDr. Mária Schmidtová, s.r.o.
Martin, Slovakia
Vaša ambulancia, s. r. o.
Martin, Slovakia
MUDr. Ondrej Gajdoš
Medzev, Slovakia
Medic I+H s.r.o.
Medzilaborce, Slovakia
JANMED, s.r.o.
Michalovce, Slovakia
Cardio Clinic s.r.o.
Moldava nad Bodvou, Slovakia
G.Praktik s.r.o.
Moldava nad Bodvou, Slovakia
HODOSI-MED s.r.o
Moldava nad Bodvou, Slovakia
Tamice,s.r.o.
Moldava nad Bodvou, Slovakia
LEK - NO, s.r.o.
Námestovo, Slovakia
TOMICI s.r.o.
Nesvady, Slovakia
Timimed s. r. o.
Nitra, Slovakia
VERKIAD s.r.o.
Nitra, Slovakia
VALETUDO s.r.o.
Nitrianske Hrnčiarovce, Slovakia
RODMED s.r.o.
Nové Zámky, Slovakia
Duo medical s.r.o.
Pezinok, Slovakia
PALMED, s.r.o.
Podolínec, Slovakia
MEDIPRAX s.r.o
Poprad, Slovakia
PULSE medicine, s.r.o
Poprad, Slovakia
GP - PRAKTIK, s.r.o.
Prešov, Slovakia
KNG s.r.o.
Prešov, Slovakia
MDPRAK, s.r.o.
Prešov, Slovakia
RM - MEDICAL s.r.o.
Prievidza, Slovakia
CorMedicus s.r.o.
Ruskov, Slovakia
Jklinik s.r.o
Ružomberok, Slovakia
PT Care s.r.o.
Spišský Hrušov, Slovakia
MUDr. Boris Piteľ
Stakčín, Slovakia
MEDICATEK s.r.o.
Starý Tekov, Slovakia
VINOVA Group s.r.o.
Strekov, Slovakia
AVK MEDIC, s.r.o.
Štúrovo, Slovakia
GPII Medical s.r.o.
Tekovské Lužany, Slovakia
MUDr. Peter MARKO, s.r.o.
Veľká Lomnica, Slovakia
Resutík s.r.o.
Veľký Krtíš, Slovakia
MUDr. Viera Čuchranová
Vinne, Slovakia
JOMED, spol. s r.o.
Vranov nad Topľou, Slovakia
MUDr. Orság Juraj, s.r.o.
Želiezovce, Slovakia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Hatala, PhD
Chief Scientist and Founder
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2021
First Posted
April 14, 2022
Study Start
November 22, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share