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Application of Telemedicine for Dermatological Emergency Patients (Telederm)

Primary Purpose

Dermatological Emergency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedicine for dermatological emergency patients
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatological Emergency focused on measuring Emergency Room, Manchester Triage System, Telemedicine, Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uniklinik RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A: Control group

B: Telemedicine for dermatological emergency patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Waiting time [min]
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

Number of differences between the personally and the telemedical diagnosis and therapy proposal
An internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.

Full Information

First Posted
July 12, 2016
Last Updated
August 28, 2018
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02836665
Brief Title
Application of Telemedicine for Dermatological Emergency Patients
Acronym
Telederm
Official Title
Application of Telemedicine for Dermatological Emergency Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatological Emergency
Keywords
Emergency Room, Manchester Triage System, Telemedicine, Patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
B: Telemedicine for dermatological emergency patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Telemedicine for dermatological emergency patients
Intervention Description
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 Measure Information:
Title
Waiting time [min]
Description
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.
Time Frame
1 emergency visit [approximately 2 hours]
Secondary Outcome Measure Information:
Title
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Description
An internal control is carried out as the same investigator comes personally to the emergency room to check its telemedical diagnosis and therapy proposal.
Time Frame
1 emergency visit [approximately 2 hours]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Villa, Dr. med.
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23901863
Citation
Marsden J, Windle J, Mackway-Jones K. Emergency triage. Emerg Nurse. 2013 Jul;21(4):11. doi: 10.7748/en2013.07.21.4.11.s11. No abstract available.
Results Reference
background

Learn more about this trial

Application of Telemedicine for Dermatological Emergency Patients

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