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, Andrea Szentesi, Andrea Párniczky, Péter J Hegyi, Szabolcs Kiss, Mária Földi, Fanni Dembrovszky, Anna Kanjo, Piroska Pázmány, András Varró, Árpád Csathó, Zsuzsanna Helyes, Zoltán Péterfi, László Czopf, István Kiss, Antal Zemplényi, Dóra Czapári, Eszter Hegyi, Dalma Dobszai, Emőke Miklós, Attila Márta, Dominika Tóth, Richard Farkas, Nelli Farkas, Béla Birkás, Erika Pintér, Gábor Pethő, Borbála Zsigmond, Andrea Sárközi, Anikó Nagy, Péter Hegyi, Bálint Erőss, Zsolt Molnár, Zsolt Szakács, Noémi Zádori, Lajos Szakó, Szilárd Váncsa, Márk Félix Juhász, Klementina Ocskay, Nóra Vörhendi, Katalin Márta, Andrea Szentesi, Andrea Párniczky, Péter J Hegyi, Szabolcs Kiss, Mária Földi, Fanni Dembrovszky, Anna Kanjo, Piroska Pázmány, András Varró, Árpád Csathó, Zsuzsanna Helyes, Zoltán Péterfi, László Czopf, István Kiss, Antal Zemplényi, Dóra Czapári, Eszter Hegyi, Dalma Dobszai, Emőke Miklós, Attila Márta, Dominika Tóth, Richard Farkas, Nelli Farkas, Béla Birkás, Erika Pintér, Gábor Pethő, Borbála Zsigmond, Andrea Sárközi, Anikó Nagy, Péter Hegyi

Abstract

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 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.

Methods: PROACTIVE-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 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.

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

Conflict of interest statement

There are no financial or other competing interests among the principal investigator, the included participants, or any member of the trial.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, interventions, and assessments according to the SPIRIT statement. The asterisk indicates that the anticipated finishing date is the end of the pandemic or development of the vaccine, but no more than 1 year from the enrolment of the last participant

References

    1. Cucinotta D, Vanelli M. WHO declares COVID-19 a pandemic. Acta Biomed. 2020;91(1):157–160.
    1. Ferguson NM, Laydon D, Nedjati-Gilani G, et al. Impact of non-pharmaceutical interventions (NPIs) to reduce COVID-19 mortality and healthcare demand. Imperial College London. 10.25561/77482. Accessed 16 Mar 2020.
    1. Mizumoto K, et al. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship Yokohama, Japan. Eurosurveillance. 2020;25(10):2000180.
    1. Nishiura H, Kobayashi T, Miyama T, et al. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19). Int J Infect Dis. 2020;94:154–55. 10.1016/j.ijid.2020.03.020.
    1. Chen N, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507–513. doi: 10.1016/S0140-6736(20)30211-7.
    1. Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020;323(15):1499–500.
    1. Novel Coronavirus Pneumonia Emergency Response Epidemiology, T The epidemiological characteristics of an outbreak of 2019 Novel coronavirus diseases (COVID-19) in China. Zhonghua Liu Xing Bing Xue Za Zhi. 2020;41(2):145–151.
    1. Arentz M, Yim E, Klaff L, et al. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020;323(16):1612–14.
    1. Chan KS, et al. SARS: prognosis, outcome and sequelae. Respirology (Carlton, Vic.) 2003;8 Suppl:S36–S40. doi: 10.1046/j.1440-1843.2003.00522.x.
    1. Nassar MS, et al. Middle East respiratory syndrome coronavirus (MERS-CoV) infection: epidemiology, pathogenesis and clinical characteristics. Eur Rev Med Pharmacol Sci. 2018;22(15):4956–4961.
    1. MacIntyre CR, et al. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018;18(1):637. doi: 10.1186/s12879-018-3548-0.
    1. Dhama K, et al. COVID-19, an emerging coronavirus infection: advances and prospects in designing and developing vaccines, immunotherapeutics, and therapeutics. Hum Vaccin Immunother. 2020:1–7.
    1. Pang J, et al. Potential rapid diagnostics, vaccine and therapeutics for 2019 novel coronavirus (2019-nCoV): a systematic review. J Clin Med. 2020;9(3):E623. doi: 10.3390/jcm9030623.
    1. Liang W, et al. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020;21(3):335–337. doi: 10.1016/S1470-2045(20)30096-6.
    1. Leung C. Clinical features of deaths in the novel coronavirus epidemic in China. Rev Med Virol. 2020;30(3):e2103.
    1. Yang J, et al. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020;94:91–5.
    1. Bao Y, et al. 2019-nCoV epidemic: address mental health care to empower society. Lancet. 2020;395(10224):e37–e38. doi: 10.1016/S0140-6736(20)30309-3.
    1. Xiang Y-T, et al. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020;7(3):228–229. doi: 10.1016/S2215-0366(20)30046-8.
    1. Prince M, et al. No health without mental health. Lancet. 2007;370(9590):859–877. doi: 10.1016/S0140-6736(07)61238-0.
    1. Fischbeck S, et al. Determinants of illness-specific social support and its relation to distress in long-term melanoma survivors. BMC Public Health. 2018;18(1):511. doi: 10.1186/s12889-018-5401-1.
    1. Liu W, et al. Analysis of factors associated with disease outcomes in hospitalised patients with 2019 novel coronavirus disease. Chin Med J. 2020. 10.1097/CM9.0000000000000775.
    1. Peng YD, et al. Clinical characteristics and outcomes of 112 cardiovascular disease patients infected by 2019-nCoV. Zhonghua Xin Xue Guan Bing Za Zhi. 2020;48(0):E004.
    1. 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;123:65–70. doi: 10.1016/j.ypmed.2019.03.002.
    1. Chan A-W, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Chow S-C, Chang M. Adaptive design methods in clinical trials–a review. Orphanet J Rare Dis. 2008;3(1):11. doi: 10.1186/1750-1172-3-11.
    1. Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020. 10.1001/jama.2020.2648.
    1. Force ADT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307(23):2526–2533.
    1. Mutsaerts MAQ, et al. Randomized trial of a lifestyle program in obese infertile women. N Engl J Med. 2016;374(20):1942–1953. doi: 10.1056/NEJMoa1505297.
    1. Villareal DT, et al. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011;364(13):1218–1229. doi: 10.1056/NEJMoa1008234.
    1. Richard Hatchett, A.-M.T. CEPI welcomes UK Government’s funding and highlights need for $2 billion to develop a vaccine against COVID-19. 2020 [cited 2020 2020/03/19]; Available from: .
    1. Organisation, W.H . Guidance for managing ethical issues in infectious disease outbreaks. 2016.
    1. Zhang H, Shao F, Gu J, Li L, Wang Y. Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic. JAMA. 2020;323(18):1844–6.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir