Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telemedicine in the Generals Practitioners Office

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04168554
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Brief Summary:

Pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination.

Goal is to determine:

  1. Check practical feasability
  2. Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much more unreliable to do a physical examination a larger study is deemed unsafe)

Condition or disease Intervention/treatment
Respiratory Distress Syndrome Pneumonia Bronchiolitis Croup Croup; False Asthma Bronchial Hyperreactivity Device: Telemedicine

Detailed Description:

40 pediatric patients seen by a general practitioner (GP) whom the GP has referred or wants to refer to a pediatrician for clinical evaluation are included in this study.

Study is designed in 2 parts. Part 1 is at the emergency room in the hospital Part 2 is at the GPs office

The pediatrician sees the patient through a telemedicine consultation. Then sees the patient in real life to see if what was seen during telemedicine corresponds with the real life consultation.

With telemedicine and real life consultation the pediatrician rates the patient as either a candidate to go home or to be admitted. With the telemedicine consultation there is also an option "in doubt: i want to see the patient in real life".

Also with both telemedicine and real life examination the pediatrician scores the patient using the respiratory observation scale (Siew et al, 2016)

Goal is to:

  1. Check practical feasability
  2. Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much harder to do a physical examination

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilotonderzoek Naar Het Gebruik Van Telemedicine Bij Het Beoordelen Van Het Benauwde Kind in de Huisartsenpraktijk English: The Use of Telemedicine in the General Practitioners Office for a Child With Respiratory Symptoms: a Pilot Study
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
Phase 1 and Phase 2

20 patients studied in the emergency room with a pediatrician not presen in the ER performing the telemedicine examination from a distance (ie an office down the hall) followed directly by a face-to-face

20 patients included in the general practitioners office, telemedicine is performed from within the hospital to the GPs office.

Patient is then still referred to the hospital in order to check whether the telemedicine and face-to-face examination are somewhat similarce physical examination

Device: Telemedicine
Patient is examined using telemedicine




Primary Outcome Measures :
  1. Discharge or admitted? [ Time Frame: within 30-60 minutes after inclusion ]
    Patients are categorized in one of three categories through telemedicine-evaluation Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted" Group 3: "In doubt between group 1 and group 2, emergency room consultation required" FTF evaluation: Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted"

  2. Respiratory Observation Scale [ Time Frame: within 30-60 minutes after inclusion ]
    Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress


Secondary Outcome Measures :
  1. Patient reported experience measure [ Time Frame: within 60 minutes after telemedicine evaluation ]
    questionnaire on patient / parent satisfaction with regard to the telemedicine

  2. Doctor reported experience measure [ Time Frame: within 4 weeks after inclusion of patients ]
    Interview with participating doctors with regard to satisfaction of the telemedicine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with any type of respiratory disease
Criteria

Inclusion Criteria:

  • Pediatric patients with respiratory symptoms whom are referred by a general practitioner to be evaluated by a pediatrician

Exclusion Criteria:

  • Infants younger than 2 months of age
  • 19 years and older
  • Ex-premature with post-conceptional age <48 weeks
  • Congenital heart disease
  • Down Syndrome
  • Immune deficiency
  • Pre-existent pulmonary disorder (Broncho-pulmonary dysplasia, Cystic Fibrosis)
  • Pre-existent neurological disorders
  • Apnea's
  • Patients with respiratory distress with dehydration symptoms
  • Patients who have already been treated with salbutamol inhalers of nebulizer - Emergency patient with respiratory insufficiency
  • Technical problems which cause a delay longer than 10 minutes before a video-connection is made
  • expected delay before commencing telemedicine consultation of longer than 30 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04168554


Contacts
Layout table for location contacts
Contact: Mendel Ottow, Drs, MD +31880058888 mottow@rijnstate.nl
Contact: Margreet Wessels, MD, PhD +31880058888 secretariaatkindergeneeskunde@rijnstate.nl

Sponsors and Collaborators
Rijnstate Hospital
Investigators
Layout table for investigator information
Principal Investigator: Margreet Wessels, MD, PhD Rijnstate Hospital

Publications:
Layout table for additonal information
Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT04168554    
Other Study ID Numbers: 2019-1384
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rijnstate Hospital:
Telemedicine
Respiratory distress
Pediatric
General practitioner
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchiolitis
Croup
Bronchial Hyperreactivity
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Laryngitis
Laryngeal Diseases
Otorhinolaryngologic Diseases