Research Research Survey

A Retrospective, Non-Interventional, Multi-Centre Cohort Study on Olfactory and Gustatory outcomes among Long COVID-19 patients

Patient information sheet

You are invited to participate in a research study being and looking at the incidence of sensory symptoms in participants who have COVID-19 symptoms developed during or after an infection and continuing for more than 12 weeks; and/or ongoing symptomatic COVID symptoms between 4 and 12 weeks after the start of acute symptoms. We will also study the incidence of psychological symptoms in post-covid participants. In addition, recent literature suggests that some patients who survive COVID-19 are likely to have some psychological and neurological symptoms.  

1.What is the purpose of the study?

To screen post-COVID-19 patients OR long COVID-hauler for olfactory, gustatory and psychological symptoms . The current study is design to collect the data two times (12 month each) during 24 months of the study. The knowledge will assist in deepening understanding of the long-term or Post-exposure impact of COVID-19 population thus facilitate strategies, prevention and treatment of olfactory, gustatory and psychological symptoms.

2.Who is conducting this study?

The current study involve multi-center research team at private Traditional and Chinese Medicine (T&CM) clinic in collaborated with Xiamen university Malaysia MoU’s (T&CM) private sector to observational study with Long COVID-19 patients.

3.Why have I been invited to participate in this study?

According to the NICE guidelines on long-COVID-19; Post-COVID-19 syndrome (symptoms developed during or after an infection and continuing for more than 12 weeks; and ongoing symptomatic COVID (symptoms between 4 and 12 weeks after the start of acute symptoms) is the definitions of the current study.

4.What if I don’t want to take part in this study or if I want to withdraw later?

Participation in this study is voluntary and your decision will not affect the medical management.  If you wish to withdraw from the study you can do so at any time without justifying your decision.  If you do withdraw from the study, all of the data already collected about you as part of the study will be destroyed and no data or information collected will be used in anyway by the researchers or sent outside this institution. No additional information will be collected for the purposes of this study and you will not be contacted again.

5.What does this study involve?

Participation in this study involves allowing the study investigators to interview. The study involve questionnaire.  The recruitment was made initially according to eligible criteria. One of the research investigators will meet you at private Traditional and Chinese Medicine (T&CM) clinic. A follow up survey will be done at 12 months after first survey. The follow-up survey will be in the form of telephonic interview answering a series of questions in-case if participant unable to visit the clinic. This will assist us to determine if there have been any changes during that course of time. The research will be using a set of screening tools (questionnaire) called Post Traumatic Stress Scale (PTSS-14); Impact of Events Scale-Revised (IES-R); Depression Anxiety Stress Scales (DASS 21). The following tools measure some of the symptoms you may be experiencing as a result of being through post-COVID-19.  

6.Will my taking part in this study be kept confidential?

You have the right to privacy and all information that is collected during this study is confidential to the extent permitted by the applicable laws and regulations.  Your study data will be made anonymous by the assignment of a unique number to you alone.  All data collected from you will then be identified by this number. No data which could be used to identify you will be transferred from your medical notes. The medical information collected during this study will then be transferred into study database(s) and processed to allow the results of this study to be analysed and reported or published for scientific purposes. Paper records including contact information will be stored in locked room accessible only to authorized study personnel.  Electronic information will be kept on password-protected computers accessible only to authorized study personnel. Your identity will be kept confidential at all times. Your personal information will only be disclosed with your permission, except as required by law.

7.Are there risks to me in taking part in this study?

No questions will be asked of you about any specific instances or memories of your time during COVID-19 pandemic. However, it is possible that you may experience some discomfort or distress as you may recollect some unpleasant memories during your COVID-19 time. Participation in the study will ensure that distress can be potentially diagnosed and appropriate referral made. In the unlikely event that you do feel distressed by any of the questions, we would encourage you to discuss any concerns with the study coordinator or your General Practitioner.

8.Will I benefit from the study?

This study aims to look at the olfactory, gustatory and psychological simpact of post-COVID-19 and gain further medical knowledge. This study may help to improve treatment for others with similar conditions, and the results of the study will be published in a major international medical journal. You may not receive any direct benefits from this research.

9.Will taking part in this study cost me anything, and will I be paid?

Participation in this research study will not cost you anything. You will not be paid or receive any financial benefits from taking part in this research study.

10.What happens with the results?

The results obtained will be collated and published in medical journals, conference presentations and other professional forums.  In any publication, information will be provided in such a way that you cannot be identified. Results of the study will be provided to you, if you wish.

11.What should I do if I want to discuss this study further before I decide?

When you have read this information, the study investigator will discuss it with you and clarify any queries you may have. If you would like to know more at any stage, please do not hesitate to contact the study coordinator.

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