TelemedicineTelemedCovNCT04990570
Telemedicine (Virtual Clinic) for Pediatric Surgery During Covid-19 Pandemic
An observational study of Telemedicine and Virtual Clinic, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Saudi Arabia.
Trial summary
Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service to Pediatric Day-case Surgical Patients in the Current Era of Covid-19 Pandemic: A Non-randomized Controlled Study Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Telemedicine, Virtual Clinic, Covid19
- What is being tested?
- Telemedicine in the form Virtual clinic via video consultation
- How many people
- 1,396 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2019to 31 Jul 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 14 years
- All sexes
- Child
Study population: Pediatric surgical patients, with age ranging from 1 month till 14 yrs old, in need to surgical consultation and further management of their issues in the era of Covid-19 pandemic, with the majority being rendered from approach to the OPD because of Covid-19 associated regulatory precautions notably lockdown period and Curfew
Who may be able to join
- Pediatric patients, with surgical conditions or consultations
- Mindful parents, motivated to use this remote interaction technology
- Available equipment (smart phone, computer or laptop, or tablet and strong stable internet connection with Ethernet coverage)
Who cannot join
- Patients older than 14 yrs of age
- Parents/patients refuse this method of interaction
- Equipment shortage
- Poor internet connection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service for Pediatric Day-case Surgical Patients in the Current Era of Covid -19 Pandemic: A Non-randomized Controlled Study
Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service to Pediatric Day-case Surgical Patients in the Current Era of Covid-19 Pandemic: A Non-randomized Controlled Study
Read the detailed description
Children often get sick, either from congenital or acquired lesions. The Covid-19 associated regulatory precautions had made the process of seeking medical advice getting more difficult and much challenging. In this article, we aim to present our experience in utilization of telemedicine, specifically the virtual clinic via video consultation, in sorting and guiding the pediatric surgical patients, evaluate the effectiveness, and document its results in giving a convenient solution for this heavily distressing problem.
Materials and Methods:
This prospective study addressed the utilization of telemedicine, specifically the virtual clinic via video consultation in the field of pediatric surgery in the current era of Covid-19 pandemic. Data recorded for analysis included demographic data, condition distribution (system/body region affected), conversation duration, ultimate fate of the consultations. Service was evaluated by on-line patient questionnaire ranging from 1 to 5.
Study was carried out at 3 pediatric surgery tertiary centers (Prince Mohammed bin Abdulaziz Hospital in Riyadh, Alyamamah Obstetric \& Children's hospital in Riyadh, and Al-Azhar University hospitals in Cairo) on pediatric surgical patients, in the period from June 2020 to July 2021, in comparison to the statistics of the period from June 2019 till June 2020. All patients' guardians enrolled in the study had electronically signed a written informed consent before commencement of a video consultation. The study was approved by the Institutional Review Board and ethics committee (Registration number: H7D4-2020-0051E). The main objective was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Primary outcome measurements included attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction. Secondary outcome measurements included time interval from appointment request till the actual encounter, encounter duration, and fate of the video conversations.
All patients are requested to register in the MOH registry (including ID and phone numbers, address, \& e-mail), and are given instructions on how to use the certified applications to organize their access to the service via approved applications at any time. Also, on-call pediatric surgery specialists were ready all the time.
Telemedicine (virtual clinic via video consultation), between a well-trained expert pediatric surgeon and a motivated child's caregiver, effectively bridges the gap caused by the regulatory precautions mandated by the current Covid-19 pandemic.
Statistical analysis:
It will be performed with IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Data will be presented as mean, standard deviation, number \& percentage, using Chi-squared test (X2) for qualitative data. The significance level will be set at P > 0.05.
- Discussion will focus on demonstrating and achieving the main objective that was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Points of discussion will include attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction, fate of the video conversations.
- Conditions
- Telemedicine, Virtual Clinic, Covid19, Pandemic
- Being tested
- Telemedicine in the form Virtual clinic via video consultation
- Keywords
- Telemedicine;, Covid-19 Pandemic;, Pediatric Surgery;, Children;, Video Conversation;, Patient's Privacy;, Data Security, Health-care Service, Day-case Surgery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine in the form Virtual clinic via video consultationOther
Pediatric patients, with age ranging from 1 month-14 years, with surgical problems, encountered during the era of Covid-19 pandemic.
Some of them seen at the OPD clinic, while the majority failed to attend because of Covid-19 associated lock-down and Curfew, thus, rendering their approach to the service.
Telemedicine, in the form of Virtual clinic, was utilized to address the distressing problem of difficult approach of patients to the pedia surgery OPD because of Covid-19 pandemic restrictive regulatory precautions, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship \& encounter.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric day-case surgical patients, encountered via Virtual clinic from June 2020 till July 2021 | Pediatric patients, with age ranging from 1 month-14 years, with day-case surgical problems, encountered during the era of Covid-19 pandemic.
Telemedicine, in the form of Virtual clinic, was utilized to address this distressing problem, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship \& encounter. Receives: Other: Telemedicine in the form Virtual clinic via video consultation | |
| Control group comprising of patients scheduled to the OPD clinic from June 2019 till June 2020 | Cases of office OPD appointments in the period from June 2019 till June 2020 will be included as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of patients
Age in years
Measured: 1 year
Condition distribution
Condition distribution in percentage
Measured: 1 year
Conversation duration
Conversation duration in minutes
Measured: 1 year
Attendance rate
Attendance rate in percentage
Measured: 1 year
Cancellation rate
Cancellation rate in percentage
Measured: 1 year
Rate of re-admissions
Rate of re-admissions in percentage
Measured: 1 year
Secondary outcomes (2)
Ultimate fate of the interview
Ultimate fate of the interview in ratio
Measured: 1 year
Patient satisfaction questionnaire
Patient satisfaction degree in numbers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Jun 2019
- Primary completion7 Jun 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,396 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
- Investigators
- Muhammad Elsayed AH Mahmoud, MD, Principal investigator, Al-Azhar University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990570
- Sponsor's protocol ID
- Al-AzharTelemedicineinCovid-19
- Acronym
- TelemedCov
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service for Pediatric Day-case Surgical Patients in the Current Era of Covid -19 Pandemic: A Non-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04990570
- Acronym / sponsor ID
- TelemedCov / Al-AzharTelemedicineinCovid-19
- Conditions
- Telemedicine, Virtual Clinic, Covid19, Pandemic
- Keywords
- Telemedicine;, Covid-19 Pandemic;, Pediatric Surgery;, Children;, Video Conversation;, Patient's Privacy;, Data Security, Health-care Service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,396 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service to Pediatric Day-case Surgical Patients in the Current Era of Covid-19 Pandemic: A Non-randomized Controlled Study
Detailed description
Children often get sick, either from congenital or acquired lesions. The Covid-19 associated regulatory precautions had made the process of seeking medical advice getting more difficult and much challenging. In this article, we aim to present our experience in utilization of telemedicine, specifically the virtual clinic via video consultation, in sorting and guiding the pediatric surgical patients, evaluate the effectiveness, and document its results in giving a convenient solution for this heavily distressing problem.
Materials and Methods:
This prospective study addressed the utilization of telemedicine, specifically the virtual clinic via video consultation in the field of pediatric surgery in the current era of Covid-19 pandemic. Data recorded for analysis included demographic data, condition distribution (system/body region affected), conversation duration, ultimate fate of the consultations. Service was evaluated by on-line patient questionnaire ranging from 1 to 5.
Study was carried out at 3 pediatric surgery tertiary centers (Prince Mohammed bin Abdulaziz Hospital in Riyadh, Alyamamah Obstetric \& Children's hospital in Riyadh, and Al-Azhar University hospitals in Cairo) on pediatric surgical patients, in the period from June 2020 to July 2021, in comparison to the statistics of the period from June 2019 till June 2020. All patients' guardians enrolled in the study had electronically signed a written informed consent before commencement of a video consultation. The study was approved by the Institutional Review Board and ethics committee (Registration number: H7D4-2020-0051E). The main objective was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Primary outcome measurements included attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction. Secondary outcome measurements included time interval from appointment request till the actual encounter, encounter duration, and fate of the video conversations.
All patients are requested to register in the MOH registry (including ID and phone numbers, address, \& e-mail), and are given instructions on how to use the certified applications to organize their access to the service via approved applications at any time. Also, on-call pediatric surgery specialists were ready all the time.
Telemedicine (virtual clinic via video consultation), between a well-trained expert pediatric surgeon and a motivated child's caregiver, effectively bridges the gap caused by the regulatory precautions mandated by the current Covid-19 pandemic.
Statistical analysis:
It will be performed with IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Data will be presented as mean, standard deviation, number \& percentage, using Chi-squared test (X2) for qualitative data. The significance level will be set at P > 0.05.
- Discussion will focus on demonstrating and achieving the main objective that was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Points of discussion will include attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction, fate of the video conversations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric day-case surgical patients, encountered via Virtual clinic from June 2020 till July 2021 | – | Other: Telemedicine in the form Virtual clinic via video consultationPediatric patients, with age ranging from 1 month-14 years, with day-case surgical problems, encountered during the era of Covid-19 pandemic. Telemedicine, in the form of Virtual clinic, was utilized to address this distressing problem, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship \& encounter. |
| Control group comprising of patients scheduled to the OPD clinic from June 2019 till June 2020 | – | –Cases of office OPD appointments in the period from June 2019 till June 2020 will be included as a control group |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric surgical patients, with age ranging from 1 month till 14 yrs old, in need to surgical consultation and further management of their issues in the era of Covid-19 pandemic, with the majority being rendered from approach to the OPD because of Covid-19 associated regulatory precautions notably lockdown period and Curfew
Key inclusion criteria (3 listed)
- Pediatric patients, with surgical conditions or consultations
- Mindful parents, motivated to use this remote interaction technology
- Available equipment (smart phone, computer or laptop, or tablet and strong stable internet connection with Ethernet coverage)
Key exclusion criteria (4 listed)
- Patients older than 14 yrs of age
- Parents/patients refuse this method of interaction
- Equipment shortage
- Poor internet connection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine in the form Virtual clinic via video consultationPediatric patients, with age ranging from 1 month-14 years, with surgical problems, encountered during the era of Covid-19 pandemic. Some of them seen at the OPD clinic, while the majority failed to attend because of Covid-19 associated lock-down and Curfew, thus, rendering their approach to the service. Telemedicine, in the form of Virtual clinic, was utilized to address the distressing problem of difficult approach of patients to the pedia surgery OPD because of Covid-19 pandemic restrictive regulatory precautions, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship \& encounter. | Other | Pediatric day-case surgical patients, encountered via Virtual clinic from June 2020 till July 2021 |
Primary outcome
Age of patients
Time frame: 1 year
Age in years
Condition distribution
Time frame: 1 year
Condition distribution in percentage
Conversation duration
Time frame: 1 year
Conversation duration in minutes
Attendance rate
Time frame: 1 year
Attendance rate in percentage
Cancellation rate
Time frame: 1 year
Cancellation rate in percentage
Rate of re-admissions
Time frame: 1 year
Rate of re-admissions in percentage
2 secondary outcomes
Ultimate fate of the interview
Time frame: 1 year
Patient satisfaction questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: Yes. Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
Related trials for Telemedicine
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Elsayed AH Mahmoud, MD principal investigator
Al-Azhar University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine and Virtual Clinic, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of patients (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.