Clinical trial NCT06655337: Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU)
Official title: Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Disease
Acute Hospitalization
Coughing
Back Pain
Abdominal Pain (AP)
Patient Discharge
Patient Readmission
Mobile Health Apps
Mobile Health Technology (mHealth)
Patient Reported Outcome (PRO)
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
Lead sponsor: Mobile Health AG
Sponsor class: INDUSTRY
Collaborators: name: Palleos Healthcare GmbH
First posted: 2024-10-23
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days
timeFrame: 7 (± 1) days after the initial AAU admission
Secondary outcomes:
measure: Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 28 (± 1) days.
timeFrame: 28 (± 1) days after the initial AAU admission
measure: Incidence of AAU Readmissions within 7 (± 1) days
timeFrame: 7 (± 1) days after the initial AAU admission
measure: Incidence of AAU Readmissions within 28 (± 1) days
timeFrame: 28 (± 1) days after the initial AAU admission
measure: Incidence of Emergency Hospitalizations within 7 (± 1) days
timeFrame: 7 (± 1) days after the initial AAU admission
measure: Incidence of Emergency Hospitalizations within 28 (± 1) days
timeFrame: 28 (± 1) days after the initial AAU admission
measure: Incidence of Consultations of Other Medical Providers within 7 (± 1) days
timeFrame: 7 (± 1) days after the initial AAU admission
measure: Incidence of Consultations of Other Medical Providers within 28 (± 1) days
timeFrame: 28 (± 1) days after the initial AAU admission
measure: Agreement Between ePRO-Derived AE Severity Index and Physician-Assessed AE Severity
timeFrame: 7 (± 1) days after the initial AAU admission
measure: Differences Between ePRO-Derived AE Severity and Physician-Assessed AE Severity Ratings
timeFrame: 7 (± 1) days after the initial AAU admission
measure: Number of Participant-Reported Symptoms by Severity
timeFrame: Daily over the 7 (± 1) day observation period
measure: Evolution of Participant-Reported Symptoms Over Time
timeFrame: Daily over the 7 (± 1) day observation period
measure: Participant-Assessed Usability and Usefulness of the Smartphone App
timeFrame: Day 7 (± 1) after the initial AAU admission
Other outcomes:
Locations:
city: Horgen
country: Switzerland
facility: Notfallzentrum See-Spital Horgen
state: Zurich
Study officials:
References: