- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Aachen, Tyskland, 52074
- Uniklinik RWTH Aachen
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: 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.
|
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Waiting time [min]
Tidsramme: 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]
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Tidsramme: 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]
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Luigi Villa, Dr. med., RWTH Aachen University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16-033
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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