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

Background: Early reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5-26% and overall mortality can rise to 11% of the recognized cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for prevention and treatment...

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Published in:Trials 2020
Main Authors: Erőss, Bálint, Molnár, Zsolt, Szakács, Zsolt, Zádori, Noémi, Szakó, Lajos, Szilárd Váncsa, Juhász, Félix, Ocskay, Klementina, Vörhendi, Nóra, Márta, Katalin, Szentesi, Andrea, Párniczky, Andrea, Hegyi, Péter J, Kiss, Szabolcs, Földi, Mária, Fanni Dembrovszky, Kanjo, Anna, Pázmány, Piroska, Varró, András, Csathó, Árpád, Helyes, Zsuzsanna, Péterfi, Zoltán, Czopf, László, Kiss, István, Antal Zemplényi, Czapári, Dóra, Hegyi, Eszter, Dobszai, Dalma, Emőke Miklós, Márta, Attila, Tóth, Dominika, Farkas, Richard, Farkas, Nelli, Birkás, Béla, Pintér, Erika, Pethő, Gábor, Zsigmond, Borbála, Sárközi, Andrea, Nagy, Anikó, Hegyi, Péter
Format: Text Resource
Language:English
Subjects:
Clinical trials
Coronaviruses
COVID-19
Health education
Lifestyles
Medical research
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Summary:Background: Early reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5-26% and overall mortality can rise to 11% of the recognized cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for prevention and treatment alike. We aim to compare the effects of a World Health Organisation (WHO) recommendations’ based education and a personalised complex preventive lifestyle intervention package (based on the same WHO recommendation) on the outcomes of the COVID-19. Methods: PROACTIVE-19 is a pragmatic, randomized 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 randomized into two groups: (A) general health education; (B) personalized health education. Participants will go through 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. 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 han 48 hours) 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 one 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 registration: The 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.
DOI:10.21203/rs.3.rs-49162/v2