COVID-19 Clinical Trial
— PROACTIVE-19Official title:
Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)
Verified date | January 2022 |
Source | University of Pecs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.
Status | Terminated |
Enrollment | 449 |
Est. completion date | September 30, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | The inclusion criteria are: 1. age over 60 years; 2. informed consent to participate. The exclusion criteria are: 1. confirmed COVID-19 infection (active or recovered); 2. hospitalization at screening for eligibility; 3. someone was already enrolled in the study from the same community/household (to avoid potential crosstalk between the study arms). |
Country | Name | City | State |
---|---|---|---|
Hungary | Institute for Translational Medicine, University of Pécs | Pécs |
Lead Sponsor | Collaborator |
---|---|
University of Pecs |
Hungary,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases | The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death.
48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure <65 mm Hg, and/or serum lactate >2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) <300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure <65 mmHg and/or serum lactate >2 mmol/L) |
12 months | |
Secondary | The number of general practitioner visits | The number of participants, who required general practitioner visit assessed by the investigator. | 12 months | |
Secondary | The number of emergency, hospital admission and intensive care admission | The number of participants, who required the admission to each type of level of care assessed by the investigator. | 12 months | |
Secondary | Length of hospitalization and intensive care unit stay | The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records. | 12 months | |
Secondary | Organ dysfunction | The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU. | 12 months | |
Secondary | Lifestyle changes | The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.
The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress. One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely. |
12 months | |
Secondary | The cost of care | The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed. | 12 months |
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