Acute DiseaseEffiDuxNCT06655337
Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU)
A study testing Smartphone Application for Post-Discharge Symptom Monitoring in people with Acute Disease and Acute Hospitalization, run by Mobile Health AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Disease, Acute Hospitalization, Coughing
- What is being tested?
- Smartphone Application for Post-Discharge Symptom Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Sep 2025to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Notfallzentrum See-Spital Horgen
Horgen, Canton of Zurich, 8810
Lauri Roellin, med. pract., +41447281111, Lauri.Roellin@see-spital.ch
About this study
Official title: 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:
Read more
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).
- Conditions
- Acute Disease, Acute Hospitalization, Coughing, Back Pain, Abdominal Pain (AP), Patient Discharge
- Being tested
- Smartphone Application for Post-Discharge Symptom Monitoring
- Keywords
- Acute Disease, Patient Discharge, Patient Readmission, Coughing, Back Pain, Abdominal Pain, Mobile Health Applications, Remote Monitoring, Post-discharge Care, Symptom Monitoring, Health Behaviour, Telemedicine, Randomized Controlled Trial
- Medical subject headings
- Acute Disease, Cough, Back Pain, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Application for Post-Discharge Symptom MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: medidux App | Experimental | 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. Receives: Device: Smartphone Application for Post-Discharge Symptom Monitoring |
| Control Arm: Standard Post-Discharge Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 (± 1) days after the initial AAU admission
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 7 (± 1) after the initial AAU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start28 Sep 2025
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mobile Health AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palleos Healthcare GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655337
- Sponsor's protocol ID
- AAUEffidux
- Acronym
- EffiDux
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06655337
- Acronym / sponsor ID
- EffiDux / AAUEffidux
- Conditions
- Acute Disease, Acute Hospitalization, Coughing, Back Pain, Abdominal Pain (AP), Patient Discharge
- Keywords
- Acute Disease, Patient Discharge, Patient Readmission, Coughing, Back Pain, Abdominal Pain, Mobile Health Applications, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Mobile Health AGIndustry (pharma, biotech, devices)
- Collaborators
- Palleos Healthcare GmbH
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: medidux App | Experimental | Device: Smartphone Application for Post-Discharge Symptom MonitoringParticipants 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. |
| Control Arm: Standard Post-Discharge Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Smartphone Application for Post-Discharge Symptom MonitoringThis 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. | Device | Intervention Arm: medidux App |
Primary outcome
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days
Time frame: 7 (± 1) days after the initial AAU admission
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.
12 secondary outcomes
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 28 (± 1) days.
Time frame: 28 (± 1) days after the initial AAU admission
Incidence of AAU Readmissions within 7 (± 1) days
Time frame: 7 (± 1) days after the initial AAU admission
Incidence of AAU Readmissions within 28 (± 1) days
Time frame: 28 (± 1) days after the initial AAU admission
Incidence of Emergency Hospitalizations within 7 (± 1) days
Time frame: 7 (± 1) days after the initial AAU admission
Incidence of Emergency Hospitalizations within 28 (± 1) days
Time frame: 28 (± 1) days after the initial AAU admission
Incidence of Consultations of Other Medical Providers within 7 (± 1) days
Time frame: 7 (± 1) days after the initial AAU admission
Incidence of Consultations of Other Medical Providers within 28 (± 1) days
Time frame: 28 (± 1) days after the initial AAU admission
Agreement Between ePRO-Derived AE Severity Index and Physician-Assessed AE Severity
Time frame: 7 (± 1) days after the initial AAU admission
Differences Between ePRO-Derived AE Severity and Physician-Assessed AE Severity Ratings
Time frame: 7 (± 1) days after the initial AAU admission
Number of Participant-Reported Symptoms by Severity
Time frame: Daily over the 7 (± 1) day observation period
Evolution of Participant-Reported Symptoms Over Time
Time frame: Daily over the 7 (± 1) day observation period
Participant-Assessed Usability and Usefulness of the Smartphone App
Time frame: Day 7 (± 1) after the initial AAU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application for Post-Discharge Symptom Monitoring in people with Acute Disease and Acute Hospitalization, run by Mobile Health AG at 1 site in Switzerland.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Trojan, MD (+41763430200, andreas.trojan@mobilehealth.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days (time frame: 7 (± 1) days after the initial AAU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.