Official Title
Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)
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.

Recruiting
SARS-CoV-2
Coronavirus
COVID-19
2019-nCoV
2019nCoV

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.
Group B

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.
Group A

Eligibility Criteria

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).

Eligibility Gender
All
Eligibility Age
Minimum: 60 Years
Countries
Hungary
Contacts

Péter Hegyi, MD, PhD, DSc
+36703751031
hegyi2009@gmail.com

Bálint Erőss, MD
eross.balint@pte.hu

Péter Hegyi, MD, PhD, DSc
Study Chair
Insitute for Translational Medicine, University of Pécs, HU

University of Pecs
NCT Number
Keywords
Coronavirus
health education
personalized health education
randomized controlled trial
intensive care
multi organ failure
prevention
MeSH Terms
Coronavirus Infections