Telemedicine in the Generals Practitioners Office

NCT04168554 | Unknown DMC FDA Device

• 1 other identifier: 2019-1384
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.Check practical feasability
2. 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)

Conditions

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

Keywords

Telemedicine; Respiratory distress; Pediatric; General practitioner

Outcome Measures

Primary Outcomes (2)

• 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"

  within 30-60 minutes after inclusion

• 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

  within 30-60 minutes after inclusion

Secondary Outcomes (2)

• Patient reported experience measure

  within 60 minutes after telemedicine evaluation

• Doctor reported experience measure

  within 4 weeks after inclusion of patients

Study Arms (1)

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

Telemedicine DEVICE

Patient is examined using telemedicine

Phase 1 and Phase 2

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with any type of respiratory disease

You may qualify if:

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

You may not qualify if:

• Infants younger than 2 months of age
• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Related Publications (1)

• 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.

  PMID: 26908666 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Laryngitis; Laryngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margreet Wessels, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mendel Ottow, Drs, MD

CONTACT

+31880058888; mottow@rijnstate.nl

Margreet Wessels, MD, PhD

CONTACT

+31880058888; secretariaatkindergeneeskunde@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 19, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share