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

Árpád Csathó¹  Béla Birkás¹  András Varró²  István Kiss³  László Czopf⁴  Zoltán Péterfi⁵  Antal Zemplényi⁶  Andrea Sárközi⁷  Borbála Zsigmond⁷  Anikó Nagy⁷  Emőke Miklós⁸  Attila Márta⁸  Dóra Czapári⁸  Dominika Tóth⁸  Richard Farkas⁸  Dalma Dobszai⁸  Zsolt Molnár⁹  Eszter Hegyi^1,10  Andrea Párniczky^1,11  Nelli Farkas^1,12  Fanni Dembrovszky^1,13  Péter J. Hegyi^1,13  Klementina Ocskay^1,13  Szilárd Váncsa^1,13  Noémi Zádori^1,13  Katalin Márta^1,13  Márk Félix Juhász^1,13  Nóra Vörhendi^1,13  Zsolt Szakács^1,13  Lajos Szakó^1,13  Mária Földi^1,14  Szabolcs Kiss^1,14  Anna Kanjo^1,15  Piroska Pázmány^1,15  Bálint Erőss^1,16  Andrea Szentesi^1,17  Péter Hegyi^1,18  Erika Pintér^1,19  Zsuzsanna Helyes^1,19  Gábor Pethő^1,19 

[1] Department of Behavioral Sciences, Medical School, University of Pécs, Pécs, Hungary;Department of Pharmacology and Pharmacotherapy, University of Szeged, Szeged, Hungary;Department of Public Health, Medical School, University of Pécs, Pécs, Hungary;Division of Cardiology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary;Division of Infectious Diseases, 1st Department of Medicine, Medical School, University of Pécs, Pécs, Hungary;Health Technology Assessment Center, University of Pécs, Pécs, Hungary;Division of Pharmacoeconomics, Department of Pharmaceutics, Faculty of Pharmacy, University of Pécs, Pécs, Hungary;Heim Pál National Pediatric Institute, Budapest, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Department of Anaesthesiology and Intensive Therapy, Poznan University for Medical Sciences, Poznan, Poland;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Faculty of Law, University of Szeged, Szeged, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Heim Pál National Pediatric Institute, Budapest, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Institute Bioanalysis, Medical School, University of Pécs, Pécs, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;János Szentágothai Research Centre, University of Pécs, Pécs, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;János Szentágothai Research Centre, University of Pécs, Pécs, Hungary;Centre for Translational Medicine, Department of Medicine, University of Szeged, Szeged, Hungary;Doctoral School of Clinical Medicine, University of Szeged, Szeged, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;János Szentágothai Research Centre, University of Pécs, Pécs, Hungary;Heim Pál National Pediatric Institute, Budapest, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Translational Medicine Foundation, Szeged, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Translational Medicine Foundation, Szeged, Hungary;Centre for Translational Medicine, Department of Medicine, University of Szeged, Szeged, Hungary;Institute for Translational Medicine, Medical School, University of Pécs, Szigeti út 12, H-7624, Pécs, Hungary;Translational Medicine Foundation, Szeged, Hungary;János Szentágothai Research Centre, University of Pécs, Pécs, Hungary;Centre for Translational Medicine, Department of Medicine, University of Szeged, Szeged, Hungary;János Szentágothai Research Centre, University of Pécs, Pécs, Hungary;Department of Pharmacology and Pharmacotherapy, Medical School, University of Pécs, Pécs, Hungary;

关键词: COVID-19;    SARS-CoV-2;    nCov-2019;    Public health;    Randomised controlled trial;    Prevention;   

DOI  :  10.1186/s13063-020-04733-0

来源: Springer

【 摘 要 】

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.DiscussionThese 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.

【 授权许可】

CC BY