Telemedicine in the Generals Practitioners Office

NCT ID: NCT04168554

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-11-30

Brief Summary

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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)

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Telemedicine

Intervention Type DEVICE

Patient is examined using telemedicine

Interventions

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Telemedicine

Patient is examined using telemedicine

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margreet Wessels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Central Contacts

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Mendel Ottow, Drs, MD

Role: CONTACT

+31880058888

Margreet Wessels, MD, PhD

Role: CONTACT

+31880058888

References

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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.

Reference Type BACKGROUND
PMID: 26908666 (View on PubMed)

Other Identifiers

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2019-1384

Identifier Type: -

Identifier Source: org_study_id

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