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 Hungarian population over the age of 60 years without confirmed COVID 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, száraz bor a cukorbetegség kezelésében 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 estimated sample size is subjects per study arm. The planned duration of the follow-up is a minimum of 1 year. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older population.
At the time of writing this study protocol, there are more thanconfirmed cases with 37, fatalities across countries, according to the Center For Systems Science and Engineering CSSE at Johns Hopkins University, including cases and 15 deaths in Hungary. The tendency predicts that the epidemic is far from its peak [ 2 ].
As often seen in the case of other epidemics, most cases can be asymptomatic or develop only mild symptoms and remain undiagnosed. Therefore, it is difficult to estimate the true incidence and the disease outcomes precisely [ 34 ]. These numbers are comparable to the outcomes of earlier coronavirus epidemics [ 910 ] and more severe than H1N1 pandemics in [ 11 ].
Significant efforts have been invested in research and development to re-target existing and discover new pharmacological treatments and preventive strategies against COVID [ 12 ], as indicated by the number of submitted protocols of the currently recruiting randomised trials on ClinicalTrials.
Nevertheless, it must be noted that we lack evidence-based targeted pharmacological therapy for prevention and treatment alike [ 13 ]. None of the registered studies investigates the effects of lifestyle interventions in the prevention of poor outcomes in the COVID epidemic. Advanced age and pre-existing comorbidities, such as cancer, cardiovascular disease, or diabetes mellitus, predispose to a more severe disease course and ICU admission [ 6141516 ]. The high risk of being infected with COVID as well as the social distancing and quarantining as primary recommendations for the suppression of virus transmission may generate a high level of anxiety and mental stress [ 1718 ].
In infected patients, better mental health might even have a positive impact on disease progression and survival [ 1920 ]. Therefore, efforts for better coping with the aversive psychological states caused by the COVID outbreak have high importance in mental health resilience.
The role of lifestyle factors and fitness in the severity of COVID has remained unexplored except for two recent studies. The latter seemingly contradicts the results of a very recent registry analysis of almostparticipants where higher body mass index indirectly, better nutritional status proved to diabetes mellitus latest research neutral or even preventive although against non-COVID upper airway infections [ 23 ].
These suggest that personalised lifestyle interventions via education copyright transfer form international journal of diabetes in developing countries counselling could be beneficial for COVID outcomes. We did not find any complex lifestyle intervention aiming to improve outcomes of epidemic respiratory diseases by a comprehensive literature search.
It is likely driven by the difficulty of organising clinical trials with lifestyle interventions. Most problems arise from the following circumstances of epidemics; 1 Exceptionally rapid response is required from the healthcare system. Unsurprisingly, no randomised clinical trial has been performed, to investigate the effects of a multicomponent preventive lifestyle intervention on the outcomes of COVID epidemic.
Our main objective is to evaluate the effects of a personalised multicomponent lifestyle intervention aiming to improve the outcomes of COVID infection in the population vércukor szintek 60 years in a randomised clinical trial. Methods Design The study protocol is structured following Spirit [ 24 ].
This design allows interim analyses and necessary modifications of the sample size of the ongoing trial to ensure adequate power a cukorbetegek kezelése babokkal 25 ]. This Act and Decree would not have allowed commencing the clinical trial as it would have amounted to a criminal offence.
The Steering Committee SC will be led by PH principal investigator, gastroenterologist, a specialist in internal medicine and clinical pharmacology.
SC members will be BE gastroenterologist, a specialist in internal medicine and primary careASz interdisciplinary unitZM intensive care specialistand ZH pharmacologist, a specialist in clinical pharmacology. There will be independent members as well, and the SC will include a patient representative. The SC will supervise the trial primarily and will make decisions regarding all critical questions e.
The sponsor had no role in the design of the trial and will have no access to the randomisation codes or the data. The study will have independent members, including physicians and a safety manager LCto comply with current ethical regulations.
Data of these subjects will not be recorded; only anonymous feedback will be given. Patients were not included in the recruitment and conduct of the study. Immediately after publications, study results will be disseminated to the population above 60 years of age via the electronic media when, depending on which study arm will better, either general or personal lifestyle intervention will be delivered.
Our interventions do not impose a considerable financial burden on patients; therefore, such compensation will not be required. Volunteering patients, who helped us to test the interventions, claimed that the time and efforts needed to participate in the study and follow the recommendations of the interventions are entirely reasonable and acceptable.
Study population Inclusion and exclusion criteria The inclusion criteria of our selective primary prevention programme are as follows: 1 age over 60 years that is, high-risk individuals and 2 informed consent to participate. Recruitment The population will be informed about the study and the contact details via social media platforms, newspaper, radio, and television advertisements. Flow and timing A toll-free phone number will be available for all interested in participation.
By dialling this number, the participant will be informed about the trial through a pre-recorded voice message, including the study rationale, conditions of participation, the process of the study, and the information on data protection. Willing participants will be redirected to an available operator, who will ascertain eligibility. Following verbal consent and randomisation, the operator will obtain key personal information of the participants and all study-related information Fig.
The allocation will not and cannot be concealed from the operator, but it will be concealed from everyone else participants, caregivers, outcome assessors.
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 Full size image Interventions Participants will be randomised into two groups: A general health education and B personalised health education. They 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.
Both groups will receive the same line of questioning to assess habits concerning these domains Suppl. Group A: Questioning will be done in the order as mentioned above, followed by a general health education aiming towards improvement of these factors with general recommendations the expected mean duration is approximately 10 min. Group B: Questioning will be done in the same structured order, but an assessment of each domain will be followed by personalised recommendations the expected mean duration is approximately 20 min.
After the first contact, there will be follow-up calls in both groups, with a matching schedule: every week in the first month, every second week in the second month, then monthly.
During these encounters, all change in all five domains since the last call will be assessed. The structure, script, and algorithm of the initial and follow-up lifestyle interventions are detailed in Suppl. The operators have received any healthcare education.
Before enrolling participants, the operators have to complete a standard training program consisting of seminars on the interventions held by medical professionals, followed by practice of scenarios.
The operators will be trained not to give additional healthcare advice, and we will not secure other information sources, including electronic and printed material. Since standard delivery of the interventions and data collection are essential, the first three and every 50th call of each operator will be assessed. Outcomes Based on literature data [ 526 ], the primary endpoint will be defined as the composite of any copyright transfer form international journal of diabetes in developing countries the following in COVID cases an accredited laboratory should verify positivitythe rate of: 1.
Secondary endpoints are the following: 1. The number of general practitioner visits 2.
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The number of emergency, hospital, and intensive care admissions 3. The length of hospitalisation and ICU stay 4. The number of organ dysfunctions and failures central nervous system, cardiovascular, respiratory, renal, liver, haematological 5.
The measurable lifestyle changes including physical and mental health 6. The costs of care The primary and secondary outcomes will be assessed upon the conclusion of the trial, at least 1 year after the enrolment of the last participant.
Randomisation and blinding Computer-generated random sequence randomisation central will be performed, after giving informed consent. Due to the expected large sample size, we will use simple randomisation. The allocation ratio will be No stratification or blocking will be applied. In the study, participants will be blinded to the knowledge of the details of differences between the interventions.
Everyone else outcome assessors, caregivers, and data analysts will be blinded regarding the allocation. We expect a full dataset for the primary endpoint since the Hungarian Ministry of Interior will provide these copyright transfer form international journal of diabetes in developing countries. If for any reason, data will be missing for the primary outcome, we will use available case analysis.
Missing more than one consecutive interventions after the initial assessment or withdrawal of consent during follow-up results in the dropout of the patients unless hospitalisation is required in the meantime.
In descriptive statistics, the count and percentage will be provided for each treatment arm for binary outcomes. For continuous outcomes, n, mean, median, interquartile Q3—Q1standard deviation, minimum, and maximum values will be provided for each treatment arm. For continuous variables, we will use t test assuming unequal variances or the Mann-Whitney test.
We will perform univariate Kaplan-Meier and Cox-regression and multivariate Cox-regression survival analysis for binary outcomes. An adjustment will be carried out at least for age, sex, and education. Mixed effect logistic regression will be conducted to estimate the effect of the multicomponent intervention on the outcomes, where the subject IDs will be used as a random subject. The model will be adjusted for changes in smoking habits, alcohol consumption, physical activity, and dietary habits or body mass index.
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Study duration The planned starting date of the study is 1 Apriland 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.
To be able to trace data to an individual subject, a subject identification code list will be used.
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This PIN will be present on all forms and documents of each individual. Electronic case report forms eCRFs will be used. The Investigator will ensure that the data in the eCRFs are accurate, complete, and legible. Any missing, implausible, or inconsistent recordings in the eCRFs will be referred back to the Investigator using a data query form DQF. They will be documented for each subject before clean file status is declared. All changes to eCRFs will be recorded.
The similarity of groups at baseline will also be checked. Written informed consent had to be replaced, due to the specific circumstances the need to maintain social distance during the pandemicby verbal consent obtained during the first call on recruitment.
The verbal consent to participate in such clinical research had not been permitted by the law previously. Therefore, the bill was amended on 24 March upon the request of our study consortium.
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This amendment enabled us to conduct this trial. After elektroforézissel diabétesz kezelésére consent of the subjects, the data will be recorded by the investigator.
Personal data are not accessible to third parties. Safety Due to the nature of the multicomponent moderate-intensity lifestyle intervention, we do not expect serious adverse events. However, minor or moderate adverse events may develop, such as alcohol and nicotine withdrawal, weight change exceeding the optimum, and the need for change in regular medications a diabetes mellitus kezelése 1 tabletták or antidiabetic drugs.
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Participants will be advised to consult their primary care physician if any non-lifestyle-related health issue arises except for COVIDrelated concerns when the call will be transferred to the COVIDspecific national helpline immediately. If a participant develops a potentially serious health problem, the chairman of the Safety Monitoring Board LC will be notified.
Discussion Neither the worldwide climax of the COVID pandemic can be foreseen nor the potential repeated outbreaks [ 2 ]. Although efforts of primary prevention i.
Better lifestyle has its unquestionable advantages not only for infectious but also for common chronic diseases including diabetes mellitus, chronic heart failure or malignant tumours. Considering the recent low numbers of reported cases and the expected trajectory of the epidemic in Hungary, it seems that we are still on time to seek for personalised and easily available public health interventions applicable for the target population.
An outbreak imposes new challenges to the process of ethical approval [ 31 ]. Most importantly, the instant reaction of both the researchers and the ethical committees is essential, while preserving the validity of scientific content [ 32 ]. Based on the results of the current study, such strategies could be introduced in other countries. Lifestyle counselling is expected to reduce mental distress, smoking, and alcohol consumption; increase physical activity; and favourably change the body mass along with the body composition.
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Strengths and limitations We aim to apply lifestyle interventions considered to be safe in a broad population of subjects exposed at high risk of a severe course of COVID The expected health benefits of the interventions considerably exceed its potential harms.
With this study design, we can evaluate the effectiveness of 1 the offer of lifestyle intervention vs 2 that of the actual uptake of or compliance to the lifestyle intervention. We expect that the moderate intensity of the personalised multicomponent lifestyle intervention will maximise the effectiveness and, at the same time, prevents low adherence. In addition to the expected beneficial effects regarding the infection, other protective changes are likely regarding cardiovascular and malignant morbidity and mortality on the long-term.
The interventions are easy to be delivered while being affordable and implementable for the vast majority of the population. We expect that there will be limitations in this study [ 30 ].
We define cross-contamination that participants on different arms deliberately and unknowingly communicate with each other, leading to the loss of the true effect of lifestyle interventions.
To minimise the risk of cross-contamination, we decided to include only one subject from communities with multiple potential candidate participants. Although we can evaluate the actual uptake of the lifestyle interventions, its validity is uncertain due to the patient-reported nature of the data.
To overcome this, we use sample size-readjustment adaptive design, which may settle the problem with the unpredictable dropout rate as well although this method cannot counteract chronological changes in the dropout rate throughout the evolution of the pandemic.
All data on secondary outcomes are provided by participants and other, less reliable indirect data sources. We anticipate that volunteers give a representative sample of the target population, but we cannot exclude that our study population will be somewhat better educated and highly motivated. Despite the thorough training of the operators, inter-operator variability may be present. Additional information and plans A follow-up study PROACTIVE PLUS is planned to follow up patients, in which blood samples serum and plasma from every patient will be stored to analyse immunoglobulins later if required and to build a biobank for a future clinical study.