CClinicalTrials.gg
Status unknownNCT04168554Updated Nov 19, 2019

Telemedicine in the Generals Practitioners Office

An observational study in Respiratory Distress Syndrome, Pneumonia and Bronchiolitis, sponsored by Rijnstate Hospital. Status unknown. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Rijnstate Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
40
Ages
3 Months to 18 Years
Sex
All
01

Study 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)
Read the 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
02

Conditions studied

  • Respiratory Distress Syndrome
  • Pneumonia
  • Bronchiolitis
  • Croup
  • Croup; False
  • Asthma
  • Bronchial Hyperreactivity

Keywords

  • Telemedicine
  • Respiratory distress
  • Pediatric
  • General practitioner
03

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients with any type of respiratory disease

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceTelemedicine

    Patient is examined using telemedicine

05

What researchers measure

Primary outcomes

  1. Discharge or admitted?

    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"

    Time frame: within 30-60 minutes after inclusion

  2. Respiratory Observation Scale

    Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress

    Time frame: within 30-60 minutes after inclusion

Secondary outcomes

  1. Patient reported experience measure

    questionnaire on patient / parent satisfaction with regard to the telemedicine

    Time frame: within 60 minutes after telemedicine evaluation

  2. Doctor reported experience measure

    Interview with participating doctors with regard to satisfaction of the telemedicine

    Time frame: within 4 weeks after inclusion of patients

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Siew L, Hsiao A, McCarthy P, Agarwal A, Lee E, Chen L. Reliability of Telemedicine in the Assessment of Seriously Ill Children. Pediatrics. 2016 Mar;137(3):e20150712. doi: 10.1542/peds.2015-0712. Epub 2016 Feb 5. PubMed 26908666 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04168554
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Dec 2019 (estimated)
Primary completion
Nov 2020 (estimated)
Completion
Nov 2020 (estimated)
Last update
Nov 19, 2019

Study contacts

Mendel Ottow, Drs, MD
Contact
mottow@rijnstate.nl
+31880058888
Margreet Wessels, MD, PhD
Contact
secretariaatkindergeneeskunde@rijnstate.nl
+31880058888
Margreet Wessels, MD, PhD
principal investigator · Rijnstate Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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