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SARS-CoV-2PROACTIVE-19NCT04321928

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

A study testing Personalized health education and General health education in people with SARS-CoV-2 and Coronavirus, run by University of Pecs at 1 site in Hungary.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2, Coronavirus, COVID-19
What is being tested?
Personalized health education and General health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
449 participants
Where
1 siteHungary
Study dates
1 Apr 2020to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

Hungary1 site

  • Institute for Translational Medicine, University of Pécs

    Pécs, 7624

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
Personalized health education, General health education
Keywords
coronavirus, health education, personalized health education, randomized controlled trial, intensive care, multi organ failure, prevention
Medical subject headings
Coronavirus Infections, COVID-19, Health Education, Multiple Organ Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized health educationBehavioural

    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.

  • General health educationBehavioural

    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.

Study groups in NCT04321928
Study groupRoleWhat they receive
Group AOtherGeneral health education arm.
Receives: Behavioral: General health education
Group BOtherPersonalized health education arm.
Receives: Behavioral: Personalized health education

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)

    Measured: 12 months

Secondary outcomes (6)

  1. The number of general practitioner visits

    The number of participants, who required general practitioner visit assessed by the investigator.

    Measured: 12 months

  2. The number of emergency, hospital admission and intensive care admission

    The number of participants, who required the admission to each type of level of care assessed by the investigator.

    Measured: 12 months

  3. Length of hospitalization and intensive care unit stay

    The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.

    Measured: 12 months

  4. Organ dysfunction

    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.

    Measured: 12 months

  5. Lifestyle changes

    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.

    Measured: 12 months

  6. The cost of care

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start1 Apr 2020
  3. Primary completion31 Aug 2021
  4. Study completion30 Sep 2021

Why it stopped: The study was terminated due to planned termination criteria (e.g., COVID-19 vaccination)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321928
Sponsor's protocol ID
IV/2428- 2 /2020/EKU
Acronym
PROACTIVE-19
Status last verified
Jan 2022
First submitted
20 Mar 2020
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020 Mar 19;91(1):157-160. doi: 10.23750/abm.v91i1.9397.

    PubMed 32191675

  • Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.

    PubMed 32183930

  • Nishiura H, Kobayashi T, Miyama T, Suzuki A, Jung SM, Hayashi K, Kinoshita R, Yang Y, Yuan B, Akhmetzhanov AR, Linton NM. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19). Int J Infect Dis. 2020 May;94:154-155. doi: 10.1016/j.ijid.2020.03.020. Epub 2020 Mar 14. No abstract available.

    PubMed 32179137

  • Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.

    PubMed 32191259

  • Dhama K, Sharun K, Tiwari R, Dadar M, Malik YS, Singh KP, Chaicumpa W. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Hum Vaccin Immunother. 2020 Jun 2;16(6):1232-1238. doi: 10.1080/21645515.2020.1735227. Epub 2020 Mar 18.

    PubMed 32186952

  • Hamer M, O'Donovan G, Stamatakis E. Lifestyle risk factors, obesity and infectious disease mortality in the general population: Linkage study of 97,844 adults from England and Scotland. Prev Med. 2019 Jun;123:65-70. doi: 10.1016/j.ypmed.2019.03.002. Epub 2019 Mar 4.

    PubMed 30844499

  • Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

    PubMed 32173574

  • Peng YD, Meng K, Guan HQ, Leng L, Zhu RR, Wang BY, He MA, Cheng LX, Huang K, Zeng QT. [Clinical characteristics and outcomes of 112 cardiovascular disease patients infected by 2019-nCoV]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Jun 24;48(6):450-455. doi: 10.3760/cma.j.cn112148-20200220-00105. Chinese.

    PubMed 32120458

  • Younge JO, Kouwenhoven-Pasmooij TA, Freak-Poli R, Roos-Hesselink JW, Hunink MM. Randomized study designs for lifestyle interventions: a tutorial. Int J Epidemiol. 2015 Dec;44(6):2006-19. doi: 10.1093/ije/dyv183. Epub 2015 Sep 15.

    PubMed 26377509

  • MacIntyre CR, Chughtai AA, Barnes M, Ridda I, Seale H, Toms R, Heywood A. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018 Dec 7;18(1):637. doi: 10.1186/s12879-018-3548-0.

    PubMed 30526505

  • Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. No abstract available.

    PubMed 32032543

  • Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, Rahman A. No health without mental health. Lancet. 2007 Sep 8;370(9590):859-77. doi: 10.1016/S0140-6736(07)61238-0.

    PubMed 17804063

  • Vancsa S, Nagy-Szakolczai A, Molontay R, Miklos E, Szentesi A, Ocskay K, Hegyi PJ, Hegyi J, Hegyi A, Hegyi E, Czapari D, Molnar Z, Eross B, Hegyi P; PROACTIVE-19 Trial Contributors. Effect of telemedicine-delivered lifestyle interventions in older adults during the COVID-19 pandemic: a nationwide two-arm randomized trial (PROACTIVE-19). Geroscience. 2026 Oct 19. doi: 10.1007/s11357-026-02585-1. Online ahead of print.

    PubMed 42895589

  • Eross B, Molnar Z, Szakacs Z, Zadori N, Szako L, Vancsa S, Juhasz MF, Ocskay K, Vorhendi N, Marta K, Szentesi A, Parniczky A, Hegyi PJ, Kiss S, Foldi M, Dembrovszky F, Kanjo A, Pazmany P, Varro A, Csatho A, Helyes Z, Peterfi Z, Czopf L, Kiss I, Zemplenyi A, Czapari D, Hegyi E, Dobszai D, Miklos E, Marta A, Toth D, Farkas R, Farkas N, Birkas B, Pinter E, Petho G, Zsigmond B, Sarkozi A, Nagy A, Hegyi P. Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial. Trials. 2020 Sep 29;21(1):809. doi: 10.1186/s13063-020-04733-0.

    PubMed 32993779

Questions about this trial

What is this clinical trial studying?

A study testing Personalized health education and General health education in people with SARS-CoV-2 and Coronavirus, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to planned termination criteria (e.g., COVID-19 vaccination)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321928, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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