Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary

Not Applicable

Terminated

• Conditions: SARS-CoV-2; COVID-19; Coronavirus; 2019-nCoV; 2019nCoV
• Interventions: Behavioral: Personalized health education; Behavioral: General health education

• Registration Number: NCT04321928
• Lead Sponsor: University of Pecs

Brief Summary

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.

Detailed Description

PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive "sample size re-estimation" design. Volunteers will be randomized into two groups: (A) generalized health education; (B) personalized health education. Participants will go through phone questioning and recommendation in 5 fields: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits, (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. In Group A: questioning will be done in sequence followed by a shared minimal intervention aimed towards improvement of these factors but without any personalized recommendation. In Group B: each assessment will be followed by specific and personalized recommendations. Assessment will be done weekly during the first month, every second week in the second month, then monthly. Considering one interim analysis for efficacy the estimated sample size is 3788 (rounded up to 3800) subject per study arm. The planned duration of the follow up is a minimum of one year.

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-04-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Personalized health education	Personalized health education arm.
Group A	General health education	General health education arm.

Primary Outcome Measures

Name	Time	Method
Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases	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)

Secondary Outcome Measures

Name	Time	Method
The number of emergency, hospital admission and intensive care admission	12 months	The number of participants, who required the admission to each type of level of care assessed by the investigator.
The number of general practitioner visits	12 months	The number of participants, who required general practitioner visit assessed by the investigator.
Length of hospitalization and intensive care unit stay	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.
Lifestyle changes	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.
Organ dysfunction	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.
The cost of care	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.

Trial Locations

Locations (1)

Institute for Translational Medicine, University of Pécs; 🇭🇺 Pécs, Hungary