- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02836665
Application of Telemedicine for Dermatological Emergency Patients (Telederm)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Aachen, Tyskland, 52074
- Uniklinik RWTH Aachen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
|
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Waiting time [min]
Tidsram: 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.
|
1 emergency visit [approximately 2 hours]
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Tidsram: 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.
|
1 emergency visit [approximately 2 hours]
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Luigi Villa, Dr. med., RWTH Aachen University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-033
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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