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

Overview

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.

Full Title of Study: “Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 21, 2021

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Other: Group A
    • General health education arm.
  • Other: Group B
    • Personalized health education arm.

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Pecs
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Hegyi Péter, Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs – University of Pecs
  • Overall Official(s)
    • Péter Hegyi, MD, PhD, DSc, Study Chair, Insitute for Translational Medicine, University of Pécs, HU
  • Overall Contact(s)
    • Péter Hegyi, MD, PhD, DSc, +36703751031, hegyi2009@gmail.com

References

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