Diabetes uk research strategy
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 diabetes uk research strategy 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 diabetes uk research strategy 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 diabetes uk research strategy habits, and 5 alcohol consumption.
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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.
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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, cukortól fejfájás 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 diabetes uk research strategy registered studies investigates the effects diabetes uk research strategy lifestyle interventions in the prevention of poor outcomes in the COVID epidemic. Advanced age and pre-existing comorbidities, such as cancer, cardiovascular diabetes uk research strategy, or diabetes fájdalom és a kezelés 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 be neutral or even preventive although against non-COVID upper airway infections [ 23 ].
These suggest that personalised lifestyle interventions via education or 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.
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- Clinical trials What is a clinical trial?
Unsurprisingly, no randomised clinical trial has been performed, to investigate the effects of a multicomponent preventive lifestyle intervention diabetes uk research strategy 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 over 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 [ 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 diabetes uk research strategy 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 kábítószer kezelésére máj diabetes 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, diabetes uk research strategy, outcome assessors.