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

NCT04321928 | Terminated DMC

• 1 other identifier: IV/2428- 2 /2020/EKU
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

Brief 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. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.

Conditions

SARS-CoV-2; Coronavirus; COVID-19; 2019nCoV

Keywords

coronavirus; health education; personalized health education; randomized controlled trial; intensive care; multi organ failure; prevention

Outcome Measures

Primary Outcomes (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)

  12 months

Secondary Outcomes (6)

• The number of general practitioner visits

  12 months

• The number of emergency, hospital admission and intensive care admission

  12 months

• Length of hospitalization and intensive care unit stay

  12 months

• Organ dysfunction

  12 months

• Lifestyle changes

  12 months

Study Arms (2)

Group A

OTHER

General health education arm.

Behavioral: General health education

Group B

OTHER

Personalized health education arm.

Behavioral: Personalized health education

Interventions

Personalized health education BEHAVIORAL

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.

Group B

General health education BEHAVIORAL

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.

Group A

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 60 years;
• informed consent to participate.

You may not qualify if:

• confirmed COVID-19 infection (active or recovered);
• hospitalization at screening for eligibility;
• someone was already enrolled in the study from the same community/household (to avoid potential crosstalk between the study arms).

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

Related Publications (13)

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• 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.

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• 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.

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• 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.

  PMID: 32191259 BACKGROUND

• 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.

  PMID: 32186952 BACKGROUND

• 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.

  PMID: 30844499 BACKGROUND

• 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.

  PMID: 32173574 BACKGROUND

• 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.

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• 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.

  PMID: 26377509 BACKGROUND

• 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.

  PMID: 30526505 BACKGROUND

• 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.

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  PMID: 17804063 BACKGROUND

• 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.

  PMID: 32993779 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Health Education; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, University of Pécs, HU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to knowledge of the details of differences between the interventions. Everyone else (outcome assessors, caregivers and data analysts) will be blinded regarding the allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 25, 2020
• Study Start: April 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)