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

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ClinicalTrials.gov Identifier: NCT04321928
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Hegyi Péter, University of Pecs

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Coronavirus COVID-19 2019-nCoV 2019nCoV Behavioral: Personalized health education Behavioral: General health education Not Applicable

Detailed Description:
PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive "sample size re-estimation" design. Volunteers will be randomized into two groups: (A) generalized health education; (B) personalized health education. Participants will go through phone 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. In Group A: questioning will be done in sequence followed by a shared minimal intervention aimed towards improvement of these factors but without any personalized recommendation. In Group B: each assessment will be followed by specific and personalized recommendations. Assessment will be done weekly during the first month, every second week in the second month, then monthly. Considering one interim analysis for efficacy the estimated sample size is 3788 (rounded up to 3800) subject per study arm. The planned duration of the follow up is a minimum of one year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 21, 2021
Estimated Study Completion Date : August 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group A
General health education arm.
Behavioral: General health education
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 B
Personalized health education arm.
Behavioral: Personalized health education
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.




Primary Outcome Measures :
  1. Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases [ Time Frame: 12 months ]

    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)



Secondary Outcome Measures :
  1. The number of general practitioner visits [ Time Frame: 12 months ]
    The number of participants, who required general practitioner visit assessed by the investigator.

  2. The number of emergency, hospital admission and intensive care admission [ Time Frame: 12 months ]
    The number of participants, who required the admission to each type of level of care assessed by the investigator.

  3. Length of hospitalization and intensive care unit stay [ Time Frame: 12 months ]
    The time spent in hospital and on the intensive care unit in days collected at the end of the trial from medical records.

  4. Organ dysfunction [ Time Frame: 12 months ]
    The number of cases, where the organ dysfunction (central nervous system, cardiovascular, respiratory, renal, liver, hematological) was present, measured daily during the hospital stay , assessed by the physician at the hospital/ICU.

  5. Lifestyle changes [ Time Frame: 12 months ]

    The reached changes in lifestyle including mental and physical status will be assessed by a questionnaire.

    The questions related to the coronavirus epidemic in will cover in 3 fields: concerns for self, concerns for family, feeling of being overwhelmed on account of news on the epidemic. The answers can be given by a scale ranging from 1-10 points. Higher score indicates greater level of distress.

    One question assessess the subjective feeling of being supported, where yes indicates adequate feeling of support and no indicates feeling of being unsupported and/or lonely.


  6. The cost of care [ Time Frame: 12 months ]
    The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The inclusion criteria are:

  1. age over 60 years;
  2. informed consent to participate.

The exclusion criteria are:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321928


Contacts
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Contact: Péter Hegyi, MD, PhD, DSc +36703751031 hegyi2009@gmail.com
Contact: Bálint Erőss, MD eross.balint@pte.hu

Locations
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Hungary
Institute for Translational Medicine, University of Pécs Recruiting
Pécs, Hungary, 7624
Contact: Péter Hegyi, MD,PhD, Dsc         
Sponsors and Collaborators
University of Pecs
Investigators
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Study Chair: Péter Hegyi, MD, PhD, DSc Insitute for Translational Medicine, University of Pécs, HU
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Hegyi Péter, Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs, University of Pecs
ClinicalTrials.gov Identifier: NCT04321928    
Other Study ID Numbers: IV/2428- 2 /2020/EKU
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Hegyi Péter, University of Pecs:
coronavirus
health education
personalized health education
randomized controlled trial
intensive care
multi organ failure
prevention
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases