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| Name | Class |
|---|---|
| Palleos Healthcare GmbH | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone Application for Post-Discharge Symptom Monitoring | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Trojan, MD | Contact | +41763430200 | andreas.trojan@mobilehealth.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Notfallzentrum See-Spital Horgen | Recruiting | Horgen | Canton of Zurich | 8810 | Switzerland |
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| 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 |
| ID | Term |
|---|---|
| D000208 | Acute Disease |
| D003371 | Cough |
| D001416 | Back Pain |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012817 | Signs and Symptoms, Digestive |
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