NCT04990570

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 2, 2021

Last Update Submit

August 14, 2021

Conditions

Keywords

Telemedicine;Covid-19 Pandemic;Pediatric Surgery;Children;Video Conversation;Patient's Privacy;Data SecurityHealth-care ServiceDay-case Surgery

Outcome Measures

Primary Outcomes (6)

  • Age of patients

    Age in years

    1 year

  • Condition distribution

    Condition distribution in percentage

    1 year

  • Conversation duration

    Conversation duration in minutes

    1 year

  • Attendance rate

    Attendance rate in percentage

    1 year

  • Cancellation rate

    Cancellation rate in percentage

    1 year

  • Rate of re-admissions

    Rate of re-admissions in percentage

    1 year

Secondary Outcomes (2)

  • Ultimate fate of the interview

    1 year

  • Patient satisfaction questionnaire

    1 year

Study Arms (2)

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.

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

Interventions

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.

Pediatric day-case surgical patients, encountered via Virtual clinic from June 2020 till July 2021

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • Patients older than 14 yrs of age
  • Parents/patients refuse this method of interaction
  • Equipment shortage
  • Poor internet connection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Elsayed Abdelhafez Mahmoud

Riyadh, 14213, Saudi Arabia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Muhammad Elsayed AH Mahmoud, MD

    Al-Azhar University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 4, 2021

Study Start

June 1, 2019

Primary Completion

June 7, 2020

Study Completion

July 31, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
August 2021 till indefinitely
Access Criteria
Send a request to the study principal-investigator
More information

Locations