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

University of Pecs

Status: Terminated

Conditions: COVID-19; 2019-nCoV; 2019nCoV; SARS-CoV-2; Coronavirus

Treatments: Behavioral: Personalized health education; Behavioral: General health education

Study type: Interventional

Funder types: Other

Identifiers

NCT04321928

IV/2428- 2 /2020/EKU

Details and patient eligibility

About

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 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.

Enrollment: 449 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 2 patient groups

Group A

Other group

Description:

General health education arm.

Treatment:

Behavioral: General health education

Group B

Other group

Description:

Personalized health education arm.

Treatment:

Behavioral: Personalized health education