Clinical trial NCT04321928: Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary
Official title: Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: SARS-CoV-2
Coronavirus
COVID-19
2019-nCoV
2019nCoV
Keywords: coronavirus
health education
personalized health education
randomized controlled trial
intensive care
multi organ failure
prevention
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 449
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases
timeFrame: 12 months
Secondary outcomes:
measure: The number of general practitioner visits
timeFrame: 12 months
measure: The number of emergency, hospital admission and intensive care admission
timeFrame: 12 months
measure: Length of hospitalization and intensive care unit stay
timeFrame: 12 months
measure: Organ dysfunction
timeFrame: 12 months
measure: Lifestyle changes
timeFrame: 12 months
measure: The cost of care
timeFrame: 12 months
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Institute for Translational Medicine, University of Pécs
Study officials:
affiliation: Insitute for Translational Medicine, University of Pécs, HU
name: Péter Hegyi, MD, PhD, DSc
role: STUDY_CHAIR
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