Evidence map›Paper›PMID 32993779›Full record

ArticleTrials2020

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.

Bálint Erőss, Zsolt Molnár, Zsolt Szakács, Noémi Zádori, Lajos Szakó, Szilárd Váncsa, Márk Félix Juhász, Klementina Ocskay, Nóra Vörhendi, Katalin Márta and 30 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04321928 (Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04321928 naterminatednot on this map

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

TypeinterventionalSponsorUniversity of PecsRan2020 to 2021Enrolled449ConditionsSARS-CoV-2, Coronavirus, COVID-19, 2019-nCoVArmsPersonalized health education, General health education
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors at 3 institutions in 2 countries.

Bálint Erőss *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Zsolt Molnár *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Zsolt Szakács *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Noémi Zádori *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Lajos Szakó *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Szilárd Váncsa *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Márk Félix Juhász *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Klementina Ocskay *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Nóra Vörhendi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Katalin Márta *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Andrea Szentesi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Andrea Párniczky *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Péter J Hegyi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Szabolcs Kiss *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Mária Földi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Fanni Dembrovszky *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Anna Kanjo *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Piroska Pázmány *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
András Varró *Department of Pharmacology and Pharmacotherapy, University of Szeged, Szeged, Hungary.
Árpád Csathó *Department of Behavioral Sciences, Medical School, University of Pécs, Pécs, Hungary.
Zsuzsanna Helyes *János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.
Zoltán Péterfi *Division of Infectious Diseases, 1st Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.
László Czopf *Division of Cardiology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.
István Kiss *Department of Public Health, Medical School, University of Pécs, Pécs, Hungary.
Antal Zemplényi *Health Technology Assessment Center, University of Pécs, Pécs, Hungary.
Dóra Czapári *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Eszter Hegyi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Dalma Dobszai *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Emőke Miklós *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Attila Márta *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Dominika Tóth *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Richard Farkas *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Nelli Farkas *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary.
Béla Birkás *Department of Behavioral Sciences, Medical School, University of Pécs, Pécs, Hungary.
Erika Pintér *János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.
Gábor Pethő *János Szentágothai Research Centre, University of Pécs, Pécs, Hungary.
Borbála Zsigmond *Heim Pál National Pediatric Institute, Budapest, Hungary.
Andrea Sárközi *Heim Pál National Pediatric Institute, Budapest, Hungary.
Anikó Nagy *Heim Pál National Pediatric Institute, Budapest, Hungary.
Péter Hegyi *Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, Pécs, H-7624, Hungary. p.hegyi@tm-centre.org.
University of Pecs · HUHeim Pál Gyermekkórház · HUUniversity of Szeged · HU

Funding

European Regional Development Fund EFOP 3.6.2-16-2017-00006 - LIVE LONGER
6 · The paper itself

Abstract

backgroundEarly reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5-26% and overall mortality can rise to 11% of the recognised cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for its prevention and treatment. We aim to compare the effects of a World Health Organization recommendation-based education and a personalised complex preventive lifestyle intervention package (based on the same WHO recommendation) on the outcomes of the COVID-19.

methodsPROACTIVE-19 is a pragmatic, randomised controlled clinical trial with adaptive "sample size re-estimation" design. Hungarian population over the age of 60 years without confirmed COVID-19 will be approached to participate in a telephone health assessment and lifestyle counselling voluntarily. Volunteers will be randomised into two groups: (A) general health education and (B) personalised health education. Participants will go through questioning and recommendation in 5 fields: (1) mental health, (2) smoking habits, (3) physical activity, (4) dietary habits, and (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. Assessment will be done weekly during the first month, every second week in the second month, then monthly. The composite primary endpoint will include the rate of ICU admission, hospital admission (longer than 48 h), and mortality in COVID-19-positive cases. The estimated sample size is 3788 subjects per study arm. The planned duration of the follow-up is a minimum of 1 year. DISCUSSION: These interventions may boost the body's cardiovascular and pulmonary reserve capacities, leading to improved resistance against the damage caused by COVID-19. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older population.

trial registrationThe study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428- 2 /2020/EKU) and has been registered at clinicaltrials.gov ( NCT04321928 ) on 25 March 2020.

Indexed as

Health EducationHealth Knowledge, Attitudes, PracticeRisk Reduction BehaviorAdaptive Clinical Trials as TopicAgedAged, 80 and overAge FactorsAlcohol DrinkingBetacoronavirusCoronavirus InfectionsCOVID-19ExerciseFeeding BehaviorFemaleHealth StatusHost-Pathogen InteractionsCOVID-19nCov-2019PreventionPublic healthRandomised controlled trialSARS-CoV-2

Identifiers

PMID32993779
PMCPMC7522906
OpenAlexW3089179352

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.