Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary (PROACTIVE-19)
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|ClinicalTrials.gov Identifier: NCT04321928|
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Coronavirus COVID-19 2019-nCoV 2019nCoV||Behavioral: Personalized health education Behavioral: General health education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7576 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a randomized controlled, adaptive, two-arm, parallel trial. The target patient population consists of adults age above 60 years without confirmed COVID-19 infection or current hospitalization. The sample size calculation suggests that 7576 subjects (3788/ each arm) are required. The allocation ratio is 1:1. Eligible participants in the generalized health education intervention arm will receive healthy lifestyle advice according to World Health Organization (WHO) principles. On the personalized education arm, participants will receive detailed informative intervention regarding lifestyle changes based on their current habits.|
|Masking:||Double (Participant, Outcomes Assessor)|
Subjects will be blinded to knowledge of the details of differences between the interventions.
Everyone else (outcome assessors, caregivers and data analysts) will be blinded regarding the allocation.
|Official Title:||Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||April 21, 2021|
|Estimated Study Completion Date :||August 21, 2021|
General health education arm.
Behavioral: General health education
Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive general health education aiming towards improvement of these factors with general recommendations following the WHO principles.
Personalized health education arm.
Behavioral: Personalized health education
Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive detailed individualized education regarding lifestyle changes based on their current habits.
- Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases [ Time Frame: 12 months ]
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)
- The number of general practitioner visits [ Time Frame: 12 months ]The number of participants, who required general practitioner visit assessed by the investigator.
- The number of emergency, hospital admission and intensive care admission [ Time Frame: 12 months ]The number of participants, who required the admission to each type of level of care assessed by the investigator.
- Length of hospitalization and intensive care unit stay [ Time Frame: 12 months ]The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.
- Organ dysfunction [ Time Frame: 12 months ]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.
- Lifestyle changes [ Time Frame: 12 months ]
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.
- The cost of care [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321928
|Contact: Péter Hegyi, MD, PhD, DScfirstname.lastname@example.org|
|Contact: Bálint Erőss, MDemail@example.com|
|Institute for Translational Medicine, University of Pécs||Recruiting|
|Pécs, Hungary, 7624|
|Contact: Péter Hegyi, MD,PhD, Dsc|
|Study Chair:||Péter Hegyi, MD, PhD, DSc||Insitute for Translational Medicine, University of Pécs, HU|