Sub-Study within Project ANNOTeM (Acute Neurological care in North-East-Germany with Tele-medical Support) Effects of telemedically supported differential diagnosis and therapy of epileptic seizures – a prospective, multi-center, open-label, controlled, cluster-randomized, parallel-group study
Organizational Data
- DRKS-ID:
- DRKS00013068
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-09-26
- Last update in DRKS:
- 2023-01-09
- Registration type:
- Prospective
Acronym/abbreviation of the study
ANNOTeM-EPI
URL of the study
Brief summary in lay language
Patients admitted to the clinics of the ANNOTeM network with epileptic seizures or unclear disorders of consciousness receive telemedical consultation from a specialist in the field of epilepsy. In addition, data on quality of life and understanding of disease are collected. Six months later, the study participants are contacted again and questions are asked for example about the course of the disease, possible future hospital stays and quality of life. Website www.annotem.de is currently under construction. Further informationen availabel at: https://innovationsfonds.g-ba.de/projekte/neue-versorgungsformen/annotem-akut-neurologische-versorgung-in-nord-ost-deutschland-mit-telemedizinischer-unterstuetzung.76 as well as at https://www.charite.de/service/pressemitteilung/artikel/detail/telemedizinische_vernetzung_verbessert_versorgung_neurologischer_notfaelle/
Brief summary in scientific language
Participating study centers will be cluster-randomized in clinics A with tele-epilepsy consultation and B without tele-epilepsy consultation and will change their assignment after the half of the project time. Primary analysis population is the Intention-To-Treat population which includes all enrolled participants. If the primary endpoint is missing, patient’s outcome will be treated as censored for the time of the last contact. Time until till re-hospitalization within 6 months after study inclusion due to an epileptic seizure or loss of consciousness of unknown origin will be analyzed by a cox-regression model. Sensitivity analyses will be carried out as well to adjust for potential confounders (for example gender). If within the time of 6 month recurrent hospitalizations will be observed, additionally analysis, which deal with recurrent events, will be conducted. For example a regression model by Wei-Lin-Weissfeld [1][2], fits the time until event number k depended the time till the preceding events, or a model by Prentice-Williams-Peterson[3], which fits a model for the time until event number k depended the counts of preceding events. Secondary endpoints will be analyzed in an exploratory manner, using appropriate parametric and non-parametric statistical methods, depending on their scale and distribution. Ninety-five percent confidence intervals will be calculated. Secondary analysis will be carried out for the per-protocol-population, which means missing values will not be imputed.
Health condition or problem studied
- ICD10:
- G40 - Epilepsy
- ICD10:
- G41 - Status epilepticus
- ICD10:
- R40 - Somnolence, stupor and coma
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- A with tele-epilepsy consultation: Within 48 hours after an acute hospital admission due to an epileptic seizure or unconsciousness of unknown origin, the patients are advised individually by epileptologists for about 1-2 hours. This is done via a telemedical system with voice, data and video conference communication. If possible, a third party medical history is taken in addition to the patient's own medical history. The attending physician then draws up a separate summary for the patient and the attending physician in the cooperating clinic. Baseline data (before consultation) and follow-up data (6 months after the start of the study) will be recorded.
- Arm 2:
- "B" without tele-epilepsy consultation and standard care: Only Baseline and Follow-Up (6 months after study inclusion) data will be recorded
Endpoints
- Primary outcome:
- time till re-hospitalization within 6 months after study inclusion due to an epileptic seizure or loss of consciousness of unknown origin measured in days
- Secondary outcome:
- Frequency of seizure (predefined subgroups: Newly occurring epilepsy and pre-existing epilepsy, as well as all patients with loss of consciousness with a suspected epilept. seizure) within 6 months after the index visit; Frequency of hospital admissions with similar symptoms within 6 months after the index visit; AU days (days of incapacity for work) within 6 months after the index visit; Change in quality of life (PROMIS-29, QOLIE 31, PESOS-2010E) between the index visit and 6 months after the index visit;
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Evangelisches Krankenhaus Ludwigsfelde-Teltow Ludwigsfelde
- Medical center KMG Klinikum Kyritz Kyritz
- Medical center Sana Krankenhaus Rügen Bergen
- Medical center Ameos Klinikum Ueckermünde Ueckermünde
- Medical center Krankenhaus Märkisch-Oderland Strausberg
- Medical center Sana Krankenhaus Templin Templin
- Medical center DRK Krankenhaus Luckenwalde Luckenwalde
- Medical center Havelland-Kliniken Nauen
- Medical center Havelland-Kliniken Rathenow
- Medical center Altmark-Klinikum Gardelegen
Recruitment period and number of participants
- Planned study start date:
- 2017-10-01
- Actual study start date:
- 2017-11-29
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-02-22
- Target Sample Size:
- 800
- Final Sample Size:
- 134
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients in regional care clinics with neurological emergency syndromes such as disturbances of consciousness or epileptic seizures with or without diagnosed epilepsy.
Exclusion Criteria
non-acute syndromes (>24h), non neurological syndromes
Addresses
Primary Sponsor
- Address:
- Charité Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité Universitätsmedizin BerlinDoktor Joachim WeberHindenburgdamm 3012203 BerlinGermany
- Telephone:
- +49 30450543524
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Charité Universitätsmedizin BerlinDoktor Joachim WeberHindenburgdamm 3012203 BerlinGermany
- Telephone:
- +49 30450543524
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Charité Universitätsmedizin BerlinDoktor Joachim WeberHindenburgdamm 3012203 BerlinGermany
- Telephone:
- +49 30450543524
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Gemeinsamer Bundesausschuss, InnovationsausschussWegelystrasse 810623 BerlinGermany
- Telephone:
- +49 22838211120
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-06-07
- Ethics committee number:
- EA4/114/17
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-07-03
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Weber JE, Angermaier A, Bollweg K, et al. Acute neurological care in north-east Germany with telemedicine support (ANNOTeM): protocol of a multi-center, controlled, open-label, two-arm intervention study. BMC health services research. 2020;20(1):755.
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Hebun Erdur MD, Joachim E. Weber MD, Anselm Angermaier MD et al. A Managed Care System with Telemedicine Support for Neurological Emergencies, Annals of Neurology, 2022, ana.26556
- Date of first publication of study results:
- 2022-11-18
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry