Improvement of Management and Outpatient Treatment of Patients After Emergency Department Visits Through the Use of the Smartphone App 'medidux'
Zusammenfassung der Studie
The aim of this clinical study is to investigate whether the use of the medidux™ smartphone app can optimize the management of patients who are admitted to an emergency department with non-urgent health complaints after discharge. The study includes adult patients (age ≥ 18 years) from triage groups 4 (standard) or 5 (non-urgent) of the Emergency Severity Index (ESI), who are admitted with primary symptoms such as cough, back pain, or abdominal complaints. The main question to be answered by the study is: Can the medidux™ app reduce the frequency of readmissions to the emergency department, emergency hospitalizations, or consultations with other healthcare providers within 7 days after the initial admission? The researchers will compare participants using the medidux™ app (intervention group) with those receiving standard treatment (control group) to observe potential differences in rates of readmissions, emergency admissions, and doctor visits. Participants will: a) use the medidux™ app to monitor their symptoms and vital parameters for 28 days after discharge (intervention group). b) receive follow-up assessments on day 7 and day 28 to evaluate the course of symptoms and any interactions with the healthcare system (both groups).
(BASEC)
Untersuchte Intervention
This intervention involves the use of a smartphone app designed for monitoring symptoms in patients. The app allows participants to record daily health data, including symptoms and vital parameters, for 28 days after discharge from the emergency department. It provides automatic prompts and guidance for self-management, including when to seek medical help. The app does not provide direct medical assistance but facilitates remote monitoring of symptoms to reduce readmissions and emergency hospitalizations. Follow-up consultations will be conducted on day 7 and day 28.
(BASEC)
Untersuchte Krankheit(en)
Participants in this study are patients who visited the emergency department due to cough, back pain, and/or abdominal complaints and were classified into levels 4 or 5 by the Emergency Severity Index (ESI) triage system.
(BASEC)
Participants must meet the following inclusion criteria to be eligible for the study: - Written informed consent to participate in the study. - Age ≥ 18 years. - (Self-)referral to the participating emergency department. - Cough, back pain, or abdominal complaints. - Classification by the ESI triage system into group 4 (low priority) and 5 (non-urgent). - German-speaking. - Ownership of a smartphone (or another suitable mobile device) with iOS or Android operating system. (BASEC)
Ausschlusskriterien
Participants who meet any of the exclusion criteria are not eligible to participate in the study: - Age < 18 years. - Participants whose adherence to the study protocol can be reasonably questioned, e.g., due to mental health issues, physical problems, or personal circumstances. - Participants with insufficient knowledge of how to use a smartphone (or another suitable mobile device). - Participants who are already using or plan to use another comparable electronic symptom monitoring system (e.g., CANKADO) during this study. (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
mobile Health AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. Andreas Trojan
+41763430200
andreas.trojan@cluttermobilehealth.chmobile Health AG
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.04.2025
(BASEC)
ICTRP Studien-ID
NCT06655337 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Efficiency of the “medidux” smartphone app for demission management in patients medicated in Acute Admission Unit (AAU) (BASEC)
Wissenschaftlicher Titel
Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial. (ICTRP)
Öffentlicher Titel
Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU) (ICTRP)
Untersuchte Krankheit(en)
Acute DiseaseAcute HospitalizationCoughingBack PainAbdominal Pain (AP)Patient DischargePatient ReadmissionMobile Health AppsMobile Health Technology (mHealth)Patient Reported Outcome (PRO) (ICTRP)
Untersuchte Intervention
Device: Smartphone Application for Post-Discharge Symptom Monitoring (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Signed Informed Consent Form (ICF)
- Age = 18 years
- (Self-)admission to the involved Acute Admissions Unit (AAU)
- "Lead symptom" identified as coughing, back pain or abdominal discomfort
- Participant within ESI triage system group 4 (standard) and 5 (non-urgent)
- German-speaking
- Ownership of a smartphone or other mobile device with iOS or Android operating
system
Exclusion Criteria:
- Age < 18 years
- Participant whose compliance to the study's protocol, e.g. due to mental health
problems, physical problems, or the private life situation, can be justifiably
doubted
- Participant with insufficient knowledge about the use of a smartphone or other
mobile device with iOS or Android operating system
- Participant already using or planning to use another comparable electronic
patient-reported symptom monitoring system (e.g. CANKADO) during this trial (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (� 1) days (ICTRP)
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 28 (� 1) days.;Incidence of AAU Readmissions within 7 (� 1) days;Incidence of AAU Readmissions within 28 (� 1) days;Incidence of Emergency Hospitalizations within 7 (� 1) days;Incidence of Emergency Hospitalizations within 28 (� 1) days;Incidence of Consultations of Other Medical Providers within 7 (� 1) days;Incidence of Consultations of Other Medical Providers within 28 (� 1) days;Agreement Between ePRO-Derived AE Severity Index and Physician-Assessed AE Severity;Differences Between ePRO-Derived AE Severity and Physician-Assessed AE Severity Ratings;Number of Participant-Reported Symptoms by Severity;Evolution of Participant-Reported Symptoms Over Time;Participant-Assessed Usability and Usefulness of the Smartphone App (ICTRP)
Registrierungsdatum
21.10.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Palleos Healthcare GmbH (ICTRP)
Weitere Kontakte
Andreas Trojan, MD;Lauri Roellin, med. pract., andreas.trojan@mobilehealth.ch; Lauri.Roellin@see-spital.ch, +41763430200;+41447281111 (ICTRP)
Sekundäre IDs
AAUEffidux (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06655337 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar