Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU): a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 417
- 试验地点
- 2
- 主要终点
- Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 7 (± 1) days
时间窗: 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.
次要结局
- Incidence of AAU Readmissions, Emergency Hospitalizations, and Consultations of Other Medical Providers within 28 (± 1) days.(28 (± 1) days after the initial AAU admission)
- Incidence of AAU Readmissions within 7 (± 1) days(7 (± 1) days after the initial AAU admission)
- Incidence of AAU Readmissions within 28 (± 1) days(28 (± 1) days after the initial AAU admission)
- Incidence of Emergency Hospitalizations within 7 (± 1) days(7 (± 1) days after the initial AAU admission)
- Incidence of Emergency Hospitalizations within 28 (± 1) days(28 (± 1) days after the initial AAU admission)
- Incidence of Consultations of Other Medical Providers within 7 (± 1) days(7 (± 1) days after the initial AAU admission)
- Incidence of Consultations of Other Medical Providers within 28 (± 1) days(28 (± 1) days after the initial AAU admission)
- Agreement Between ePRO-Derived AE Severity Index and Physician-Assessed AE Severity(7 (± 1) days after the initial AAU admission)
- Differences Between ePRO-Derived AE Severity and Physician-Assessed AE Severity Ratings(7 (± 1) days after the initial AAU admission)
- Number of Participant-Reported Symptoms by Severity(Daily over the 7 (± 1) day observation period)
- Evolution of Participant-Reported Symptoms Over Time(Daily over the 7 (± 1) day observation period)
- Participant-Assessed Usability and Usefulness of the Smartphone App(Day 7 (± 1) after the initial AAU admission)