FAQ

It is the component of the NIMHANS-NH-SKAN study that follows a group of individuals over time who have not experienced a stroke at the time of entry into that study. The study will add to the understanding of the mechanism underlying stroke.

Stroke is one of the common causes for disability and socio-economic consequences. The risk factors associated with these are not completely understood. Hence, this study is being implemented to understand the different risk factors associated with stroke as well as looking at the effect of these risk factors on the consequences of stroke occurring in an individual.

From this study, we will be • Monitoring the progression of a set of risk factors, including overweight/obesity, mental health/stress, non-communicable diseases, substance use, and physical activity/diet, over a span of 4 years. • Determining the incidence of stroke in specific areas, namely 2 urban wards in Bengaluru and 1 taluk in Kolar districts. • Assessing how strong is the relationship between various risk factors and the occurrence of stroke. • Developing a stroke-risk predictability calculator based on gathered data.

Stroke – risk predictability calculator is a tool designed to estimate an individual’s likelihood or probability of experiencing a stroke, based on specific risk factors (as mentioned above). In the context of our study, where we are monitoring the progression of various risk factors over a span of 4 years and assessing their association with the occurrence of stroke, the stroke risk predictability calculator would use statistical models to generate personalized risk predictions for individuals.

The study will be conducted at Byrasandra and Pattabhirama Nagar urban wards of Bengaluru city and in Mulabagilu taluka for Kolar district.

We wanted our study participant to be representing urban slum, urban non-slum and rural populations. These 2 wards of Bengaluru district selected for the study represent urban slum and urban non-slum populations across various socio-economic and demographic strata. The taluka selected in Kolar district represent rural and semi urban populations. In addition, these 2 study sites are within reasonable distance to NIMHANS. Further Kolar is a public Health Observatory for the Department of Epidemiology & Centre for Public Health, NIMHANS. Considering these the study is being conducted in Kolar and Bengaluru districts.

The study will include approximately 2 lakh eligible participants/people and they will be followed up for four years.

Permanent residents aged 30 years and above currently residing in the study area (for more than 6 months), stroke-free, and willing to participate in the study can participate in the study.

Yes. Pregnant and lactating women can participate in the study.

Those who are bedridden, unable to participate for any reason, individuals with a history of stroke at any point in their life, and those who are chronically debilitated are not eligible to participate in the study.

Once the individual decides to take part in the study, he/she will be provided with a consent form by a trained survey team (those who collect the data in the field/study location). This consent form provides all necessary information about the study to make an informed decision. After explaining them about the study he/she will be asked to sign the informed consent form by the trained survey team if they are willing to participate.

A consent form is a document provided to participants who are invited to participate in a research study. It is the procedure through which permission is sought to gather data from participants upholding respect, rights, and confidentiality of research participants. The participants will receive a thorough explanation of confidentiality and other procedural details when they decide to participate in the study. It is an ethical requirement and represents a mutual understanding between the researcher and the research participant, detailing the roles and responsibilities each party assumes towards the other throughout the research process. Once the participant signs a content form, a copy of the same will be provided to them for their reference

Trained survey team members will collect the data using a digital questionnaire either on their mobile or on a tablet. A trained survey team member will visit the participants at their households, and ask them to participate in the study. Once the participant provides consent, he or she will be asked to participate in an interaction/interview.

Generally, it takes about 30-45 minutes. It might be as long as 1 hour 30 minutes based on the interaction.

A small sample of blood will be collected from the participant's vein by qualified/trained personnel. In addition, blood pressure, height, weight, waist and hip measurement of the participant will be done.

Approximately 5-7ml of blood will be collected.

The qualified/trained personnel will collect the blood sample, using all aseptic precautions.

In our experience, almost all participants in our previous study where we collected blood samples have reported pain in very minimal to negligible. Thus, it can be considered practically painless. However, there is a possibility that certain participants may consider in painful.

Yes. Blood collection process is conducted by qualified and trained personnel, following standard safety protocols. All equipment used for blood collection, such as needles, syringes, and collection tubes, will be sterile and for single use only.

Participant can ask their concerns or questions to our data collector (trained survey team) or sample collector, if they are able to address it they will; if not, they will contact our study team and clarify their issues. There is a phone number within the consent form with whom participants can contact. Participants can ask the data collector; they will provide them with the phone number. In case the data collector or the sample collector are not available, Participants can contact or reach out to their Anaganawadi or Asha Worker. These community health workers will facilitate communication with our study team on behalf of the participants.

All the data collected using a digital questionnaire will be kept confidential in a password-protected computerized data base with access only to investigators. Hard copies of the report and questionnaire or measure-ments if any will be kept in a locked safe with access only to the study investigators. The collected blood sample will be immediately transported to the laboratory in the Department of Neurochemistry, MIMHANS, Bengaluru and/or Kolar District Hospital, Kolar and/or Sri DevarajUrs Medical College, Kolar, and will be processed. Participant’s glucose levels and lipid profiles in blood samples will be estimated. After completion of the study, samples will be stored under recommended storage conditions, with access only to study investigators.

Participants shall receive their blood test report either there is an automated message reporting system or by the study team within 15 days of collecting their blood sample.

There will be no other medical investigations done. If we need to do, we will take appropriate approvals before doing the same.

It may be used in the future for further studies in the same area of work after obtaining permission from the institute's ethical committee.

The duration of the study is 4 years. The follow-up will be conducted once every year.

Yes. The trained survey team will be following the same procedures for follow-ups as mentioned above. If there is any change in procedures, participants will be adequately informed and consent obtained and the study procedures will be conducted.

Participants are encouraged to attend all follow-ups to the best extent possible. Our trained survey team will work with participants to ensure complete participation and if necessary thy will re-schedule follows ups.

Yes. If the participant feels uncomfortable with any of the questions, measurement of height and weight, or collection of blood samples they have the right to refuse to provide the same at any point during the study.

Yes, participants have the right to withdraw from the study at any time without facing any consequences. This information is included in the informed consent process. Participant's decision on participating or not participating in the study will not impact on any of their regular benefits, facilities, treatment, health care etc. Which they might/might have received otherwise.

Participants are free to withdraw from the study at any point in time. However, the study team/trained survey team will ask for reasons which is important for us to consider during the analysis and would like to know the reasons why the participants want to withdraw from the study/ This information will be helpful to consider during the analysis.

Participation in the study may not benefit the participant directly. However, the results of the study will provide a comprehensive understanding of the natural history of stroke from the stroke-free period. Participation in the study will contribute immensely to the understanding of different factors associated with the development of stroke and eventually for better management of stroke in the community. Participants contribute to prevent stroke.

No financial compensation shall be provided to the participants.

The study aims to minimize risks. Participants will be informed of any potential risks during the informed consent process. The study involves collection of blood from the vein of the arm using a needle and syringe. Blood sample will be drawn by qualified/trained personnel under aseptic precautions using disposable needles. There is a minimal risk of bleeding. In the event of any study procedure-related harm, appropriate medical attention shall be provided by the study team. Furthermore, if participants are detected with clinical conditions that need medical attention during the study procedures, participant will be referred to the nearest facility or the medical facility of their choice. The study team will not bear the expenses related to the management of clinical conditions that are not study-related.

Participant details and information provided by the participant is subjected to confidentiality and anonymity. The personal details of the participants, such as their names, contact information, and other sensitive information are kept private and confidential through strict security measures. The information collected from the participant will be available only to the investigators. Study participants and the collected blood sample will be identified only by a unique identification number. All digital data will be kept confidential in a password protected file with access only to principal investigators. All physical data like participant information sheet, signed informed consent document etc., will be kept locked in a safe with access only to study investigators. The same may be digitally scanned & uploaded into the digital database which will be kept confidential in a password protected file with access only to study investigators.

The results of the study may be published in scientific journals, presented at conferences, and shared with the broader community (without breaching participant personal details/identity/confidentiality).

Regular updates may be provided through study website announcements and community meetings. In addition, participant’s lab related information will be provided to them.