Notfallzentrum See-Spital Horgen
Horgen, Canton of Zurich, 8810, Switzerland
Location status: Recruiting
NCT Number: NCT06655337
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Horgen, Canton of Zurich, 8810, Switzerland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 28 (± 1) days after the initial AAU admission
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.
Time frame: 7 (± 1) days after the initial AAU admission
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.
Time frame: 28 (± 1) days after the initial AAU admission
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.
Time frame: 7 (± 1) days after the initial AAU admission
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.
Time frame: 28 (± 1) days after the initial AAU admission
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.
Time frame: 7 (± 1) days after the initial AAU admission
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.
Time frame: 28 (± 1) days after the initial AAU admission
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.
Time frame: 7 (± 1) days after the initial AAU admission
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.
Time frame: 7 (± 1) days after the initial AAU admission
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.
Time frame: Daily over the 7 (± 1) day observation period
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.
Time frame: Daily over the 7 (± 1) day observation period
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).
Time frame: Day 7 (± 1) after the initial AAU admission
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.
Contact information is provided by the study sponsor or research team.
Mobile Health AG
Industry
Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial.
Acronym: EffiDux
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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