Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU) (EffiDux)

Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial.

The goal of this clinical trial is to evaluate whether the use of the medidux™ smartphone app can optimize post-discharge management for patients admitted to Acute Admission Units (AAU) with non-urgent health complaints. This trial includes adult patients (age ≥ 18) in Emergency Severity Index (ESI) triage system groups 4 (standard) or 5 (non-urgent), presenting with primary symptoms such as cough, back pain, or abdominal discomfort.

The main question it aims to answer is:

Can the medidux™ app reduce the incidence of AAU readmissions, emergency hospitalizations, or consultations with other medical providers within 7 days after initial admission?

Researchers will compare participants using the medidux™ app (intervention arm) with those receiving standard care (control arm) to observe potential differences in the rates of readmissions, emergency hospitalizations, and medical consultations.

Participants will:

• use the medidux™ app to monitor their symptoms and vital parameters for 7 days after discharge (intervention arm).
• receive follow-up consultations at day 7 and at day 28 to assess symptom progression and any healthcare interactions (both arms).

Study Overview

• Status: Recruiting
• Conditions: Back Pain; Acute Disease; Coughing; Patient Discharge; Patient Readmission; Mobile Health Apps; Abdominal Pain (AP); Acute Hospitalization; Mobile Health Technology (mHealth); Patient Reported Outcome (PRO)
• Intervention / Treatment: Device: Smartphone Application for Post-Discharge Symptom Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 417
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Trojan, MD; Phone Number: +41763430200; Email: andreas.trojan@mobilehealth.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Horgen, Canton of Zurich, Switzerland, 8810
      • Recruiting
      • Notfallzentrum See-Spital Horgen
      • Contact: Lauri Roellin, med. pract.; Phone Number: +41447281111; Email: Lauri.Roellin@see-spital.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm: medidux App; Participants in this arm will use the medidux™ smartphone application to monitor their symptoms and vital signs for 7 days following discharge from the Acute Admission Unit (AAU). The app provides health monitoring features, prompts for symptom tracking, and guidance on whether further medical consultation is required. Participants will log daily health data and receive automated reminders. The app aims to reduce post-discharge readmissions and emergency hospitalizations by providing real-time support. Follow-up assessments will be conducted at day 7 and day 28 post-discharge to evaluate symptom progression and healthcare utilization.	Device: Smartphone Application for Post-Discharge Symptom Monitoring; This intervention involves the use of a smartphone application designed for symptom monitoring. The app enables participants to log daily health data, including symptoms and vital signs, for 7 days following discharge. It provides automated prompts and guidance for self-management, including when to seek medical assistance. The app does not provide direct medical intervention but facilitates remote symptom tracking to reduce readmissions and emergency hospitalizations. Follow-up consultations are conducted at day 7 and day 28.
No Intervention: Control Arm: Standard Post-Discharge Care; Participants in this arm will receive standard post-discharge care as currently practiced in the Acute Admission Unit (AAU). This may include follow-up calls or appointments with healthcare providers to monitor symptoms and progression after discharge, but participants will not use the medidux™ app for symptom tracking or monitoring. Follow-up assessments will be conducted at day 7 and day 28 post-discharge to evaluate symptom progression and healthcare utilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days	This measure evaluates the number of participants who experience at least one AAU readmission, emergency hospitalization, or consultation with other medical providers within 7 days of the initial AAU admission. This is a binary measure (yes/no) indicating whether such an event has occurred.	7 (± 1) days after the initial AAU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 28 (± 1) days.	This measure captures the number of participants who experience at least one AAU readmission, emergency hospitalization, or consultation with other medical providers within 28 days of the initial AAU admission. This is a binary measure.	28 (± 1) days after the initial AAU admission
Incidence of AAU Readmissions within 7 (± 1) days	The number of participants who experience at least one readmission to the AAU within 7 days of their initial admission. This measure is a binary variable indicating whether a readmission has occurred.	7 (± 1) days after the initial AAU admission
Incidence of AAU Readmissions within 28 (± 1) days	The number of participants who experience at least one readmission to the AAU within 28 days of their initial admission. This is a binary variable indicating whether a readmission occurred.	28 (± 1) days after the initial AAU admission
Incidence of Emergency Hospitalizations within 7 (± 1) days	The number of participants who experience at least one emergency hospitalization within 7 days of their initial AAU admission. This is a binary variable indicating whether such an event occurred.	7 (± 1) days after the initial AAU admission
Incidence of Emergency Hospitalizations within 28 (± 1) days	The number of participants who experience at least one emergency hospitalization within 28 days of their initial AAU admission. This measure is a binary variable.	28 (± 1) days after the initial AAU admission
Incidence of Consultations of Other Medical Providers within 7 (± 1) days	This measure tracks the number of participants who consult with medical providers (outside of AAU or emergency hospitalizations) within 7 days of their initial AAU admission. It is a binary measure.	7 (± 1) days after the initial AAU admission
Incidence of Consultations of Other Medical Providers within 28 (± 1) days	This measure captures the number of participants who consult with medical providers within 28 days after their initial AAU admission. This is a binary variable.	28 (± 1) days after the initial AAU admission
Agreement Between ePRO-Derived AE Severity Index and Physician-Assessed AE Severity	This outcome assesses the agreement between the participant-reported ePRO-derived AE severity index (where 0.1 represents the least severe symptoms and 10 represents the most severe) and the AE severity index assessed by the investigator for one randomly selected symptom. The investigator uses a similar scale ranging from 0 (no symptoms) to 4 (severe symptoms). Agreement between the two assessments is calculated as a correlation coefficient.	7 (± 1) days after the initial AAU admission
Differences Between ePRO-Derived AE Severity and Physician-Assessed AE Severity Ratings	This outcome compares the differences between the participant-reported ePRO-derived AE severity index (ranging from 0.1 to 10, where higher scores represent more severe symptoms) and the investigator-assessed AE severity index (where 0 is no symptoms and 4 is severe symptoms) for a randomly selected symptom. The differences are presented in a cross-frequency table, showing any significant divergence between participant and physician assessments.	7 (± 1) days after the initial AAU admission
Number of Participant-Reported Symptoms by Severity	This outcome counts the number of participant-reported symptoms as assessed through the ePRO-derived AE severity index, which ranges from 0.1 (least severe) to 10 (most severe). Scores are linearly transformed into an index from 0 to 4, where 0 represents no symptoms and 4 represents severe symptoms.	Daily over the 7 (± 1) day observation period
Evolution of Participant-Reported Symptoms Over Time	This outcome tracks the progression of participant-reported lead symptoms over time, using the ePRO-derived AE severity index (0.1 to 10 scale, where 0.1 indicates least severity and 10 indicates most severity). The symptoms are reported daily, and the index is transformed linearly into an index from 0 (no symptoms) to 4 (severe symptoms).	Daily over the 7 (± 1) day observation period
Participant-Assessed Usability and Usefulness of the Smartphone App	Usability and usefulness of the app will be assessed based on participant responses to an 11-point Likert scale questionnaire. Participants will rate usability and usefulness across several domains, with scores ranging from 0 (does not apply) to 10 (fully applies), where 0 represents the worst outcome and 10 represents the best possible outcome for each item, such as ease of use, helpfulness in symptom management, and perceived impact on physician consultations.	Day 7 (± 1) after the initial AAU admission

Collaborators and Investigators

• Sponsor: Mobile Health AG
• Collaborators: Palleos Healthcare GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Abdominal Pain; Randomized Controlled Trial; Back Pain; Remote Monitoring; Health Behaviour; Acute Disease; Patient Discharge; Patient Readmission; Symptom Monitoring; Coughing; Mobile Health Applications; Post-discharge Care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Abdominal Pain; Acute Disease; Cough
• Other Study ID Numbers: AAUEffidux

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No