Virtual Compensatory Cognitive Training (Virtual-CCT) – A study on acceptability and feasibility

Abstract

Background:

Cognitive impairments in individuals with psychotic disorders impact day-to-day activities and social and occupational functioning (Bowie CR, 2006). Most of the cognitive interventions were developed in the west focusing mainly on clinical research and were not available in routine care. Adaptability and accessibility of these techniques in low-resource settings like India had major challenges. Keeping this in mind, Compensatory Cognitive Training (CCT), being an economical and noncomputerized intervention, was adapted to be used for an urban English-speaking population in India.

Aim:

The study aimed to determine the acceptability and feasibility of delivering CCT to persons with schizophrenia through virtual one-on-one sessions.

Materials and Methods:

Patients with a diagnosis of schizophrenia were assessed for their subjective and objective cognitive deficits. CCT was delivered for 13 participants as a virtual one – one session. Three participants dropped out midway. Semistructured interview was conducted with all ten participants who completed the intervention to understand their acceptability of Virtual CCT. Feasibility was assessed using a visual analog scale on their attendance, involvement, and comprehending ability. The mean percentile scores on cognitive domains at baseline and end of intervention were analyzed.

Results:

Significant change was observed in specific domains of cognition. Participant involvement, lesser dropout rates, and their feedback indicated that Virtual CCT is a feasible and acceptable intervention.

Conclusion:

Virtually delivered CCT appears to be an acceptable and feasible intervention to increase access to cognitive interventions for persons with schizophrenia in LAMI countries. This needs to be tested in larger populations.

Cognitive impairments are the core feature of psychotic disorders.[1] The deficits are present even before the onset of active psychotic symptoms and persistent throughout the illness. Various meta-analyses reveal that patients with schizophrenia obtain significantly lower scores on cognitive tests than healthy controls, and in particular, more significant impairments in processing speed and episodic memory were observed.[2] These deficits impact patients’ day- to-day activities and social and occupational functioning.[3] There is growing awareness regarding the association between cognition and everyday functioning in psychosis,[4,5,6,7,8] which has led to much interest in treatment methods that improve cognition.[9] For several decades, the interventions that were developed targeting these cognitive deficits focused mainly on clinical research and were not available in routine care.[10] An expert group working on cognitive remediation (CR) defined CR as a behavioral training intervention targeting cognitive deficit, using scientific learning principles, aiming to improve functional outcomes. Its effectiveness is enhanced when provided in a context (formal or informal) that provides support and opportunity for extending to everyday functioning. CR interventions are the most extensively researched interventions and have been found to be effective in targeting cognitive deficits in persons with psychosis.[11] Meta-analysis has proved that CR is the most effective intervention in improving cognitive and functional outcomes.[12] Studies of cognitive rehabilitation on severe mental illness indicate that psychosocial rehabilitation programs that include cognitive interventions have better outcomes.[13] There has been extensive research in traumatic brain injury and cognitive rehabilitation.

Cognitive therapy in schizophrenia has derived its classification from the description of traumatic brain injury, which classifies CT approaches into restorative, compensatory, and environmental.[14,15,16] The CR expert working group consensus meeting identified core features of the CR treatment and produced recommendations for its design, conduct, reporting, and implementation. Four techniques were identified: facilitation by a therapist, cognitive exercise, procedures to develop problem-solving strategies, and procedures to facilitate transfer to real-world functioning.[17] A meta-analysis found that programs including these four elements had a significantly more significant effect.[18] A multiarm, multicenter, single-blinded, adaptive trial of therapist-supported CR was designed to identify how much therapist time would provide an efficient and cost-effective CR service within UK NHS Early Intervention Services (EIS) to inform implementation. CR was delivered in three different modalities with varied levels of therapist involvement, and participants were randomized to these three arms. It was concluded that active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis.[19] A recent review examining the feasibility and acceptability of remotely delivered CR interventions identified nine studies from the western countries which delivered CR remotely. The acceptability rates were high, and caregivers’ responses were positive. On the other hand, the overall attrition rate for participants who took part in a remote CR intervention was 32.3%, which is very high compared to control conditions.[20]

Compensatory Cognitive Training (CCT), developed by Dr. Elizabeth Twamley in the United States, is a “brief, practical, low-tech, engaging to clients and portable enough to be delivered in the community” intervention.[21] This intervention focuses on 1) prospective memory, 2) conversational and task vigilance, 3) learning and memory, and 4) cognitive flexibility and problem-solving over 12 sessions. The compensatory approach aims to teach strategies that help clients work around their deficits, the restorative approach aims to rectify the deficits, and the environmental approach aims to modify the environment to reduce the cognitive demands on the individual.[22] CCT as an intervention aligns with the recommendations from the expert group. CCT, being an economical and noncomputerized intervention, was adapted to be used for an urban English-speaking population in India.[23] To make this accessible for individuals in remote areas, delivering CCT with the help of technology was considered. Since most patients have access to a smartphone but limited access to tablet computers or laptops, delivering CCT as a group intervention through a virtual platform would be challenging due to Internet connectivity and bandwidth issues. Hence, in discussion with the original author and experts like Dr. Frances Dark,[24] we aimed to test the feasibility of delivering CCT as a virtual one-to-one intervention.

MATERIALS AND METHODS

Patients attending the OPD services of the facility were screened using the inclusion and exclusion criteria. Patients in the age group of 18 to 55 years with a diagnosis of schizophrenia, having a device with a video conferencing facility and stable Internet connectivity, were approached and assessed for their reading and comprehension ability and cognitive deficits. Those with cognitive deficits were given detailed explanations about CCT, and written informed consent was obtained for participating in the study. Individuals who were acutely ill or had cognitive deficits due to other illnesses were excluded. The SCARF Ethics Committee approved the project (Approval Number: SRF-CR/16/OCT-2020 dated 06^th October 2020). All participants were provided with a participant information sheet (English or Tamil), which included all information about the study in detail in simple language. They were given the opportunity to ask questions, which was clarified by the authors. Then participants signed the informed consent form for participating in the study and also consented to use the information provided by them during the study period for publication. Participants were also informed that their data will be anonymized and only represented as codes and published.

Tools used

NIMHANS Specific Learning Disability (SLD) Battery: The SLD battery was used to screen for learning disabilities. We focused on screening individuals’ dyslexia and dysgraphia as these difficulties would interfere with our administration of the therapeutic modules.[25]

NIMHANS Neuropsychological Battery: The NIMHANS neuropsychological assessment is a standardized assessment tool used to assess cognitive deficits. The normative data have been established for Indian adults between 16 and 65. The battery’s selective subtests were used to assess memory attention and problem-solving skills.[26]

Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS): The SSTICS is a brief, 21-item self-report scale examining subjective complaints about memory, attention, praxia, and executive function in patients affected by schizophrenia. The original study exhibited good internal consistency (α =0.86) and test–retest reliability (rs =0.82).[27]

Semistructured Interviews (SSIs): SSIs aimed to understand participants’ and caregivers’ experience of CCT delivered virtually and the facilitators and barriers to receiving the intervention virtually. The interviews were conducted through zoom platform and recorded and transcribed for analysis.

Intervention session logs: All the clinicians kept detailed notes of each patient session in a purposely built log. The clinicians documented details of the session (date, duration of the session, mode of delivery, the content of the session, level of involvement of the participant, level of comprehension, compliance with HW, any distraction observed, challenges in delivering the content, family members’ involvement, and therapists’ remarks about the session). The logs were used to report the logistics of the intervention delivery. Individuals’ ability to comprehend, involvement in the sessions, and HW compliance were rated on a scale of 0 to 10 using the session log; the higher the score, the better the ability.

Intervention

The details about the CCT interventions and their components were described in our previously published paper on cultural adaptation.[23] Adaptations were made to the CCT intervention for virtual use and delivered individually. Following a discussion with Dr Frances Dark, PowerPoint presentations were used during each session to help deliver the session and online free access games (Uno cards and cognitive flexibility games) were used when necessary. Pictures were used to help in the problem-solving activity of session 10. Homework (HW) activities after every session involved tasks that an individual engages in their day-to-day life, like preparing a to-do list for a week, checking their calendar, and completing the tasks that had been prioritized for that particular day, like calling the clinician to arrange the next session (using reminders) and practicing conversation attention using strategies.

Procedure

Patients visiting SCARF OPD were screened using the inclusion and exclusion criteria. Patients fulfilling the criteria and providing informed consent were assessed for the presence of cognitive deficits using the NIMHANS neuropsychological battery, which was completed in face-to-face sessions. The participants and their families were provided with information about cognitive deficits and CCT. The adapted CCT manual was given to the participants after they provided written informed consent. Appointments were scheduled to deliver online sessions on selected video conferencing platforms based on patient choice. As the sessions were delivered one-to-one, sessions could be rescheduled to accommodate the participant’s convenience through mutual discussion. Care was taken that the sessions were completed on time by a week. The presence of family members during the one-to-one online sessions was encouraged to support patients for the sessions and in homework, though this was not mandatory. However, if the patient did not wish for his/her family member to accompany them in their sessions, we took their permission to contact the family member after the session to let them know what was done during the session to help support the patient with the homework tasks. After delivering all 12 sessions, assessments were repeated. Participants were also asked a list of questions about the session to assess the feasibility and acceptability after each session. Four researchers (LV, SG, SB, PS) who are also clinicians trained in CCT delivered the interventions one-on-one virtually. LV is a psychiatrist, and SB, PS, and SG are trained psychologists. The clinicians met regularly for peer supervision. The 12 sessions were delivered through video conferencing platforms. Sessions were delivered once or twice a week, depending on patient convenience. PowerPoint presentations were used during the sessions to facilitate discussions. Free online resources for some CCT activities (Uno game, card sorting) were used. After each session, the participants were given homework (HW) tasks to complete before the next session. Individuals’ ability to comprehend, involvement in the sessions, and HW compliance were rated on a scale of 0 to 10 (the higher the score, the better the ability) using a session log.

SSIs were conducted with the participants and the caregivers at the end of the training, that is, after the 12^th session, by SG, SB, and PS. It was ensured that the interviews were conducted by a researcher different from the researcher who delivered the intervention. The SSI guide comprised open-ended questions under various themes such as content, structure, mode of delivery, helpful and difficult topics, and challenges faced.

Analysis

Quantitative variables like average number of sessions completed per participant, dropout rate, participant involvement, comprehension ability, and compliance to homework tasks rated on a scale of 0 to 10 were used to evaluate feasibility. Student t-test was used to compare the mean percentile scores on cognitive domains at baseline and the end of the intervention. SSIs with participants and caregivers about the experience of virtually delivered CCT were transcribed, coded, and analyzed. Themes were already framed as questions in the SSI, and the content under each theme was tabulated.

RESULTS

As described in the consort diagram [Figure 1], out of the 15 participants who consented, 10 completed all 12 sessions of V-CCT. Their demographic information and illness information are tabulated in Table 1. Ten participants attended all 12 sessions, and the other 3 (23%) dropped out [Table 2]. Participants who completed all 12 sessions were assessed again using the subjective and objective cognitive measures. Baseline and endline mean scores were compared and analyzed using nonparametric tests as shown in Table 3. A significant difference was observed in the digit vigilance test, which measures sustained attention and learning scores and recall scores of the auditory verbal learning test. There was also a significant difference with regard to the subject reports of cognitive deficits as assessed using SSTICS.

Figure 1.

The consort diagram describes the participant flow in the study

Table 1:

Sociodemographic and illness profiles of the participants at baseline (n=13)

Variables	n (%) n=14
Gender
Male	06 (46.2)
Female	07 (53.8)
Age in years	35.5±8.3 years
Mean±Sd
Education in years	15.3±1.1 years
Mean±Sd
Marital Status n (%)
Married	05 (38.5)
Unmarried	07 (53.8)
Divorced/Separated	01 (7.7)
Occupation status n (%)
Employed	05 (38.5)
Unemployed	06 (46.2)
Homemaker	02 (15.4)
Duration of illness in years	13±7.5
Mean±Sd
Age of onset in years	25.4±5.6
Mean±Sd

** 14^th participant withdrew consent before intervention, and hence, their baseline data are not included in the results

Table 2:

Details about dropouts

Characteristics	n=3 (21%)
Gender (M: F)	1:2
Employment status	Employed (1) Home maker (1) Unemployed (1)
Reason	lack of time (2) internet connectivity (1)
Point of drop out	after 4th session (2) after 5th session (1)

Table 3:

Comparison of the mean percentile scores on cognition before and after V-CCT (n=10)

Variables	Mean±SD	Median (IQR)	P
Colour 1 Trails (Focussed Attention)
PERCENTILE_CT1	62.4±28.8	68 (43,88)	0.508
PERCENTILE_EL_CT1	57.6±24.4	67.5 (46,71)
CT2
PERCENTILE_CT2	50.6±21.6	44.5 (38,51)	0.646
PERCENTILE_EL_CT2	47±20.9	40.5 (39,65)
Digit Vigilance test (Sustained Attention)
PERCENTILE_DVT	26.6±25.9	11.5 (10,40)	0.779
PERCENTILE_EL_DVT	28.6±28	12.5 (9,40)
PERCENTILE_DVT_ER	37.1±32.8	26 (6,69)	0.011*
PERCENTILE_EL_DVT_ER	58.1±36.4	63.5 (31,90)
Auditory verbal learning test – Learning and Memory
PERCENTILE_LS	7±3.5	5 (5,10)	0.028*
PERCENTILE_EL_LS	13.4±9	13 (5,19)
PERCENTILE_IR	8.5±6.7	5 (5,10)	0.027*
PERCENTILE_EL_IR	17.5±17	10 (5,20)
PERCENTILE_DR	9±6.6	5 (5,10)	0.041*
PERCENTILE_EL_DR	19.8±24.4	11.5 (5,20)
PERCENTILE_LTPR	46.6±43.7	32.5 (5,95)	0.905
PERCENTILE_EL_LTPR	44.5±38	37.5 (10,95)
Tower of London – Planning ability
Mean number of problems solved at baseline	8.7±1.3	8.5 (7.7,10)	0.22
Mean number of problems solved at endline	9.3±1.4	9 (8,10.2)
SSTICS Total score
Baseline	38.6±14.9	38 (25,50)	0.008*
Endline	28.7±9.9	30 (17,37)

*=significant

Feasibility of virtually delivered CCT frequency and duration of session

Seven participants (53%) used google meet for CCT sessions, and others used zoom platform, except one person, who used skype. The majority of them opted for weekly two sessions (77%), and the remaining attended one session per week. The sessions lasted 50 to 70 minutes. The first session took a longer time (60–70 minutes) as participants had many questions about the training for the therapist. Further sessions lasted 40 to 50 minutes. Around 20% of the participants agreed for the family members to get involved in the CCT sessions.

Participant involvement in the sessions: The participants’ comprehension ability was around 70 to 80% across the sessions. Similarly, their involvement during the initial sessions ranged between 50 and 60%, but as the sessions progressed, their involvement got better and increased to 80 to 90%.

Homework (HW) tasks: HW tasks were noted to be a significant challenge for the participants. Lack of motivation, forgetting to check the HW written in their book, lack of opportunities to try out the HW tasks, and so on were the various reasons given by the participants. As the sessions progressed, participants got used to the habit of checking their notebook for HWs and other tasks to be done during the day and HW completion status improved.

Acceptability of virtual CCT: The findings from the SSIs with participants and caregivers are given in Table 4. Some of the quotes from the SSI are depicted in Table 5.

Table 4:

Themes, responses, and suggestions of the participants elicited using the SSI

Topics covered	Participant Opinions	Caregiver’s opinion	Suggestions for improvement of sessions
Content of CCT	Covered aspects of daily life situations
Structure of the sessions	Helped to stay focused		One session per week Inclusion of more games Role plays related to real life situations To provide recording of the sessions
Online mode	Around 70% of the participants felt comfortable with the online mode of delivery	It reduced their burden and saved a lot of time
Helpful Topics	Helpful strategies/techniques from the training: Strategy to improve attention during a conversation Steps involved in problem solving skills using acronyms to remember grocery list, names of persons Self-talk as a strategy to remember steps involved in doing a specific task like cooking a dish. Using calendar to schedule the activities during the day Making a to do list. Prioritizing tasks	All techniques taught were very helpful in their day today life	Additional topics were suggested such as: Social skills training, Emotion recognition, Motivation enhancement Handling work pressure and assertiveness skills
Difficult topics	Session on Problem solving skills		More examples and practice sessions
Expectations prior to the sessions	Technical and theoretical aspects would be covered
Sessions/Techniques that are useful to their day-to-day life	Participants mentioned specific techniques or strategies that they felt useful in their day-to-day life such as Brainstorming Categorization Note taking Self-talk	The LEAP principles were very useful	Need more opportunity to test the learned skills at home
Factors helped participants to stay through the sessions	Interactive sessions Techniques related to real life Use of virtual platform Flexibility approach by the therapist
Factors hindered participation	Low Motivation Lack of opportunities Network issues Initial sessions simple and draggy	Caregivers felt laziness as the most significant factor hindering participation among their loved ones
Therapists’ involvement	Had the patience to clarify doubts Knowledgeable Flexible	Dedicated and highly skilled professionals
Outcomes	Participants stated following aspects as the outcome of CCT: Improvement in their attention, able to follow instructions More organized in their day-to-day life Able to stick on to their schedules Able to communicate more confidently Problem solving skills helped them to sort out their problems and they were able to work through the problems instead of avoiding	Able to interact with people without any hesitation Daily activities have improved

Table 5:

Quotes from the SSI

Mrs.S, House wife: I joined the training expecting that it is going to be like a lecture and it will be all technical, but to my surprise the session was very interactive and delivered in simple language and the PowerPoint presentations used during each session helped me to stay focused. If you have sent me those presentations it would have been of great help for me to revise what happened during the sessions. Mr.K, part time employed: Calendar use is very helpful to me in daily life. I note down all my schedules in my diary and I am more disciplined now which makes me feel good about myself” When they were asked about strategies that they liked the most and how it helped them in their life, majority of the participants spoke about L.E.A.P (conversational attention using active Listening, Eliminate distractions, Ask questions and Paraphrase techniques) principles and how it helped them to gain confidence. Mrs.V, Home maker: Through LEAP, I gained confidence to go and talk to others. I also believe the exercises will improve my memory power. But I need to practice what was taught to me. For some participants initial sessions were boring and slow paced as they had very specific problems with attention and planning only with regard to their work situation. Some participants lacked opportunities to practice the skills learned during the session in their real life. Mr.SK, unemployed: For now, I have opportunities to use the skills only at home, remembering phone number, buying stuffs that are needed at home, note making helps. I am looking for job, once I get it I believe these skills will be more useful Mrs K, Software professional: “My main problems are at work place, not able to keep up my pace at work, using calendar and making home for my things are all very simple stuff, I am not a school going kid

DISCUSSION

Technology in delivering mental health-related services has increased substantially in recent years and has rapidly increased with the COVID-19 pandemic.[27] The recruitment of the participants, fewer dropouts, their involvement during the sessions, and compliance with the session requirements indicate that delivering CCT virtually is a feasible intervention. As reported in the IDI, attending the virtual sessions enabled them to be more decisive when scheduling the sessions with the therapist. It also reduces the travel time and cost of attending a face-to-face session, indicating the acceptability of a virtual mode of delivery. In contrast, participants of our study expressed that CCT was very practical and applicable to their day-to-day life situation, and the virtual mode of delivery using PowerPoint presentations facilitated good engagement. While other studies highlight the advantages and benefits of CCT applications and programs for the elderly population,[28,29] this study remains distinctive with its accentuation of live virtual CCT sessions with an available therapist on the other end who will provide the same guidance and support that is offered in a face-to-face session. With the limited evidence available for remotely delivered cognitive interventions using technology, it was understood that CRT interventions have high attrition rates, almost around 32%, in comparison to face-to-face interventions. The reasons for high attrition were that CRT was too demanding, participants were uncomfortable using the computer, and other reasons.[20]

The attrition rate of 23% in our study is comparable to the attrition rate of 19.5% in the randomized controlled trial (RCT) conducted at Brisbane by Frances Dark and team.[24] However, it is significantly lower when compared to the 43% attrition rate reported in the RCT conducted by the developers of CCT.[30] The lower attrition rate in our study may be attributed to various factors like the inclusion of fun activities, activities in line with real-life situations, and strategy coaching facilitated by a skilled therapist. The improved attention and verbal memory scores in our study align with the findings of various other studies using different CR approaches, indicating that CCT delivered virtually is comparably effective in improving cognition among individuals with schizophrenia.[15,16] This finding [Table 3] is also similar to those of studies done in the western countries, which used the CCT module and found it to improve attention, verbal memory, functional capacity, and subjective quality of life among persons with psychosis.[21] Meta-analysis on various approaches of CRT has also been found to be effective in improving various neurocognitive abilities like attention, working memory, planning, and cognitive flexibility.[18,19] A University of Minnesota, USA team published a study on the feasibility and preliminary efficacy of delivering cognitive training remotely using tablets. They reported that in comparison to personal desktop-based cognitive training, remotely delivered CT is feasible and results in retention rates and adherence to the training schedule.[31] The SSI conducted post intervention establishes the feasibility of virtual CCT in our study. The participant’s involvement in uninterrupted sessions through online platforms showed that virtual CCT as an intervention is feasible to be delivered through virtual platforms. Keeping the sessions interactive and using visual aids and simple language helped make the virtual one-to-one session acceptable to the participants. Using real-life examples relevant to the participant’s life also made it practical. CCT is usually delivered in groups as face-to-face sessions, which is a positive factor in facilitating more discussions and participant involvement. But when it is delivered as a one-on-one virtual session, it is important to keep in mind that the sessions are not theoretical. As stated by the participants of this study, including more games and activities might enable better engagement and further reduce dropout rates.

Strategies to improve conversation attention (example: LEAP – Listen actively, Eliminate distractions, Ask questions, Paraphrase principles) were well received and found to be valuable strategies by all the participants. Also, problem-solving skills were complex for most participants and brainstorming different solutions as a strategy took a lot of work. Problem-solving is a higher-order cognitive skill, and individuals with schizophrenia have severe impairment in this aspect.[32] Participants wanted the practice to be increased in this area. While there is a demonstration of problem-solving skills as part of the module, we suggest adding more problem-solving exercises to the session. We suggest adding one more session to the module to practice these skills depending on the participant’s need.

Compliance with homework is a challenge with any psychosocial intervention. Studies have demonstrated that better compliance with homework improves the patient’s engagement with therapy.[33] Maintaining a diary/calendar and daily checking in our study were new for most participants. Remembering homework contributed to difficulty completing HW tasks during the initial sessions. HWs being logical and relevant to the sessions, concrete and clearly defined, and therapists discussing factors leading to noncompliance with HW in sessions were the factors leading to better compliance with HW as reported in a meta-analysis.[34] In our study, as the sessions progressed, homework became more aligned with the content of the sessions, which made it logical and relatable to their current life situation. Also, engaging family members, teaching them about the importance of homework, and providing opportunities for the patients to put their skills into practice helped to improve compliance with homework.

Strengths and limitations

The study has aligned with the current trends of using technology to deliver the intervention, which is one of the strengths. Also, to create more opportunities for the participants to practice their learned skills at home, attempts were made to include family members as part of the intervention. Apart from the quantitative measures, using an SSI to understand the participant’s experience added more value to understanding the acceptability of CCT. The study also had a few limitations, having a small sample size and a follow-up assessment needing to be done to evaluate the sustainability of the effects of the CCT intervention. Since the study aimed to test the acceptability and feasibility of virtual one-on-one cognitive intervention, it is essential to acknowledge that virtual delivery of these interventions might be limited by access to technology.

CONCLUSION AND FUTURE DIRECTION

The participants accepted CCT and found it beneficial and applicable to their daily lives. Participants were comfortable with virtual sessions; some preferred one session per week to give them more time to practice the learned skills in their daily lives. Suggestions were provided to include additional sessions on improving social skills, emotional skills, and motivation. Lack of opportunity to practice skills was a common theme that emerged, emphasizing the importance of educating family members about cognitive deficits and their impact and the need to create opportunities for the clients to practice the learned skills to enable them to attain their goals.

Authors’ contributions

The authors confirm contribution to the paper as follows: Study conception and design: SG, LV, PR; Data collection: SG, LV, SB, PS; Analysis and interpretation of results: SG, LV; Draft manuscript preparation: SG, LV, SB, PS, FD, PR; All authors reviewed the results and approved the final version of the manuscript.

Ethical statement

Ethical Approval was obtained from SCARF Ethics Committee Ref No. SRF-CR/16/OCT-2020 dated 06/10/2020.

Conflicts of interest

There are no conflicts of interest.

Data availability statement

The data that support the findings of this study are available from the corresponding author, [PR], upon reasonable request.

Patients’ consent

All participants were provided with an participant information sheet (English or Tamil) which included all information about the study in detail in simple language. They were given the opportunity to ask questions which was clarified by the authors. Then participants signed the informed consent form for participating in the study and also consented to use the information provided by them during the study period for publication. Participants were also informed that their data will be anonymized and only represented as codes and published.