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Application of Telemedicine for Dermatological Emergency Patients (Telederm)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836665
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

After admission to the emergency room each dermatological patient is routinely assessed to Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis followed by randomization in two equal study groups.

Patients of group A (control group) wait routinely until the dermatological investigator in charge arrives at the emergency room. Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.

For Patients of group B (teledermatology) study-related photographs of the skin lesion and anamnesis data are uploaded to the hospital information system "medico". Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.

Subsequently an internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.

Finally both time periods patients have to wait in the emergency room for their diagnosis and therapy are compared with each other.


Condition or disease Intervention/treatment Phase
Dermatological Emergency Procedure: Telemedicine for dermatological emergency patients Not Applicable

Detailed Description:

After admission to the emergency room each dermatological patient is routinely assessed to Manchester Triage System (MTS) by the nursing staff. Thereby data are collected for anamnesis (duration of symptoms, allergies, self-medication, medical history) followed by randomization in two equal study groups.

Patients of group A (control group) wait routinely until the dermatological investigator in charge arrives at the emergency room. Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.

Time is measured from the patients admission to the emergency room up to the personnel diagnosis and therapy by the dermatological investigator in charge.

For Patients of group B (teledermatology) first of all study-related photographs of the skin lesions are taken with a tablet. After that the registration of the consult "teledermatology" is carried out by the emergency investigator in charge, who uploads the photographs as well as the data for anamnesis to the hospital information system "medico". The consult "teledermatology" can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.

Time is measured from admission to the emergency room up to the telemedical diagnosis and therapy by the dermatological investigator in charge.

Subsequently an internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.

Finally both time measurements are compared with each other.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Application of Telemedicine for Dermatological Emergency Patients
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
No Intervention: A: Control group
Patients of group A wait routinely until the dermatological investigator in charge arrives at the emergency room. Once the dermatological investigator is on site, he gives a diagnosis and proposes a therapy.
Experimental: B: Telemedicine for dermatological emergency patients
For Patients of group B study-related photographs of the skin lesion and anamnesis data are uploaded to the hospital information system "medico". Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal.
Procedure: Telemedicine for dermatological emergency patients
Study-related photographs of the skin lesion made by a tablet and anamnesis data are uploaded to the hospital information system "medico". Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal without being on site.




Primary Outcome Measures :
  1. Waiting time [min] [ Time Frame: 1 emergency visit [approximately 2 hours] ]
    Time is measured from the patients admission to the emergency room up to the personnel/telemedical diagnosis and therapy by the dermatological investigator in charge.


Secondary Outcome Measures :
  1. Number of differences between the personally and the telemedical diagnosis and therapy proposal [ Time Frame: 1 emergency visit [approximately 2 hours] ]
    An internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged ≥ 18 years
  • Written informed consent prior to study participation
  • Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel.
  • Dermatological emergency patient

Exclusion Criteria:

  • Male or female aged < 18 years
  • Missing informed consent prior to study participation
  • Patient has been committed to an institution by legal or regulatory order
  • Persons in dependence from the sponsor or working with the sponsor
  • Participation in another clinical trial within the previous 2 months

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): NCT02836665


Locations
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Germany
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Luigi Villa, Dr. med. RWTH Aachen University
Publications:
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02836665    
Other Study ID Numbers: 16-033
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by RWTH Aachen University:
Emergency Room
Manchester Triage System
Telemedicine
Patients
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Dermatologic Agents