Dermatological EmergencyTeledermNCT02836665
Application of Telemedicine for Dermatological Emergency Patients
A study testing Telemedicine for dermatological emergency patients in people with Dermatological Emergency, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatological Emergency
- What is being tested?
- Telemedicine for dermatological emergency patients
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Dermatological Emergency
- Being tested
- Telemedicine for dermatological emergency patients
- Keywords
- Emergency Room, Manchester Triage System, Telemedicine, Patients
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine for dermatological emergency patientsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| A: Control group | No intervention | 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. |
| B: Telemedicine for dermatological emergency patients | Experimental | 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. Receives: Procedure: Telemedicine for dermatological emergency patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 emergency visit [approximately 2 hours]
Secondary outcomes (1)
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.
Measured: 1 emergency visit [approximately 2 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion14 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatological EmergencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Villa, Dr. med., Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836665
- Sponsor's protocol ID
- 16-033
- Acronym
- Telederm
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23901863
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Telemedicine for Dermatological Emergency Patients
- ClinicalTrials.gov ID
- NCT02836665
- Acronym / sponsor ID
- Telederm / 16-033
- Conditions
- Dermatological Emergency
- Keywords
- Emergency Room, Manchester Triage System, Telemedicine, Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Control group | No intervention | –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. |
| B: Telemedicine for dermatological emergency patients | Experimental | Procedure: Telemedicine for dermatological emergency patientsFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine for dermatological emergency patientsStudy-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. | Procedure or surgery | B: Telemedicine for dermatological emergency patients |
Primary outcome
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.
1 secondary outcome
Number of differences between the personally and the telemedical diagnosis and therapy proposal
Time frame: 1 emergency visit [approximately 2 hours]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Background: PubMed 23901863Marsden 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Villa, Dr. med. principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine for dermatological emergency patients in people with Dermatological Emergency, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waiting time [min] (time frame: 1 emergency visit [approximately 2 hours]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.