Assessment of the function of the telemedicine device in order to report lead 2 of electrocardiogram, heart rate, body temperature, peripheral pulse rate and the level of blood oxygen
Assessment of the function of the telemedicine device in order to report lead 2 of electrocardiogram, heart rate, body temperature, peripheral pulse rate and the level of blood oxygen
Design
Two arm parallel group unblinded, non-randomised, phase 3 trial on 60 patients with cardiac arrhythmia and 20 adults without cardiac arrhythmia
Settings and conduct
This study will be conducted in the Cardiology Clinic of Babol University of Medical Sciences. Adults who refer for check-up or cardiological treatment will be assessed without any blinding in two intervention and control groups. The intervention group includes the patients who have at least one of the 6 types of common cardiac arrhythmias (including AF, VT, PSVT, PVC, PAC, or AT) and the telemedicine device is installed on their body.
The control group includes people who do not have any of the 6 common types of cardiac arrhythmia and the telemedicine device is installed on their body. Allocation of the participants to two intervention and control groups will be carried-out without randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years and over; Refer to the cardiology clinic for check-up or cardiological treatment
Exclusion criteria: The patient's inability to use the telemedicine device; Not to provide consent to participate in the study
Intervention groups
Intervention group: Patients who have at least one of the 6 common types of cardiac arrhythmias diagnosed by the cardiologist and the telemedicine device will be installed on their body.
Control group: People who do not have any of the 6 common types of cardiac arrhythmia and the the telemedicine device will be installed on their body.
Main outcome variables
Lead 2 of the electrocardiogram; Heart rate; Body temperature; Peripheral pulse rate; The level of blood oxygen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230808059080N1
Registration date:2023-08-14, 1402/05/23
Registration timing:registered_while_recruiting
Last update:2023-08-14, 1402/05/23
Update count:0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
Mohammad Taghi Hedayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0624
Email address
mt.hedayati@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-12, 1402/05/21
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the function of the telemedicine device in order to report lead 2 of electrocardiogram, heart rate, body temperature, peripheral pulse rate and the level of blood oxygen
Public title
Assessment of the function of the telemedicine device
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and over
Refer to the cardiology clinic for check-up or cardiological treatment
Exclusion criteria:
The patient´s inability to use the telemedicine device
Not to provide consent to participate in the study by the patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
12
In each participant, three times of measurement with 5-minute intervals using 3 SEMS-HIOT devices and one standard device
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.MUBABOL.REC.1401.180
Health conditions studied
1
Description of health condition studied
Atrial fibrillation and atrial flutter (AF)
ICD-10 code
I48.9
ICD-10 code description
Unspecified atrial fibrillation and atrial flutter
2
Description of health condition studied
Ventricular tachycardia (VT)
ICD-10 code
I47.2
ICD-10 code description
Ventricular tachycardia
3
Description of health condition studied
Paroxysmal supraventricular tachycardia (PSVT)
ICD-10 code
I47.1
ICD-10 code description
Supraventricular tachycardia (paroxysmal)
4
Description of health condition studied
Premature ventricular contractions (PVC)
ICD-10 code
I49.3
ICD-10 code description
Ventricular premature depolarization
5
Description of health condition studied
Premature atrial contractions (PAC)
ICD-10 code
I49.1
ICD-10 code description
Atrial premature depolarization
6
Description of health condition studied
Atrial tachycardia (AT)
ICD-10 code
I47.1
ICD-10 code description
Supraventricular tachycardia
Primary outcomes
1
Description
Lead 2 of the electrocardiogram
Timepoint
Minute 1, minute 6 and minute 11
Method of measurement
Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device.
2
Description
Body temperature
Timepoint
Minute 1, minute 6 and minute 11
Method of measurement
Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device.
3
Description
The level of blood oxygen
Timepoint
Minute 1, minute 6 and minute 11
Method of measurement
Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device.
4
Description
Peripheral pulse rate
Timepoint
Minute 1, minute 6 and minute 11
Method of measurement
Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device.
5
Description
Heart rate
Timepoint
Minute 1, minute 6 and minute 11
Method of measurement
Patient lying supine on a medical bed, after 15 minutes of rest, the medical care device (including three chest leads, an axillary thermometer and a wireless finger pulse oximeter) is installed on his body. The participant will rest again for 5 minutes and then the research primary variables will be measured. Data recording will be initiated at minute 1. With 5-minute intervals, three times of measurement will be carried out on each patient using three SEMS-HIOT devices produced by the Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences, and one time measurement with a standard device.
Secondary outcomes
1
Description
Acceptance of the device by the patient
Timepoint
At the end of the intervention
Method of measurement
By asking a question about the patient's satisfaction with the device
Intervention groups
1
Description
Intervention group: The patients who have at least one of the 6 types of common cardiac arrhythmias diagnosed by the cardiologist and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company affiliated to Technology Incubator of Babol University of Medical Sciences is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger.
Category
Diagnosis
2
Description
Control group: The adults who do not have any of the 6 types of common cardiac arrhythmias and the telemedicine device manufactured in Behbood Samane Hooshmand Teb Company is installed on their body. This device consists of three chest leads, a thermometer in the armpit and a wireless pulse oximeter that is placed on the participant's finger.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology Clinic of Babol University of Medical Sciences
Full name of responsible person
Fazel Tarkhan
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
medslums@gmail.com
Web page address
https://roshd.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
research@mubabol.ac.ir
Web page address
https://research.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fazel Tarkhan
Position
Physician and inventor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Email
medslums@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fazel Tarkhan
Position
Physician and inventor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Email
medslums@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fazel Tarkhan
Position
Physician and inventor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Email
medslums@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data of this study can be shared after de-identifying the individuals.
When the data will become available and for how long
The access period starts 3 months after the results are published.
To whom data/document is available
Data related to this study will be available both to researchers working in academic and scientific centers and to people working in industry.
Under which criteria data/document could be used
After sending the request email to the corresponding author, data related to this study will be available both to researchers working in academic and scientific centers and to people working in industry.
From where data/document is obtainable
The corresponding author with email address mt.hedayati@mubabol.ac.ir
What processes are involved for a request to access data/document
The data related to this study will be available in time up to two months after sending the request email to the corresponding author.