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CTRI Number  CTRI/2021/12/038487 [Registered on: 07/12/2021] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Educational intervention to improve diagnosis and treatment of CNS-TB 
Scientific Title of Study   The Role Of Educational Intervention In Improving Diagnosis And Treatment Of Central Nervous System Tuberculosis– A Cluster Randomized Trial (RED-TB Trial)  
Trial Acronym  RED-TB Trial  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya M R 
Designation  Assistant Professor, Neurology 
Affiliation  Department of Neurology, All India Institute of Medical Sciences, New Delhi 
Address  Room 602, Department of Neurology, Neurosciences Centre, AIIMS, Delhi

New Delhi
DELHI
110049
India 
Phone    
Fax    
Email  dr.divyamr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya M R 
Designation  Assistant Professor, Neurology 
Affiliation  Department of Neurology, All India Institute of Medical Sciences, New Delhi 
Address  Room 602, Department of Neurology, Neurosciences Centre, AIIMS, Delhi

New Delhi
DELHI
110049
India 
Phone    
Fax    
Email  dr.divyamr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya M R 
Designation  Assistant Professor, Neurology 
Affiliation  Department of Neurology, All India Institute of Medical Sciences, New Delhi 
Address  Room 602, Department of Neurology, Neurosciences Centre, AIIMS, Delhi

New Delhi
DELHI
110049
India 
Phone    
Fax    
Email  dr.divyamr@gmail.com  
 
Source of Monetary or Material Support  
World Federation of Neurology 
 
Primary Sponsor  
Name  World Federation of Neurology Grant in Aid  
Address  World Federation of Neurology Chester House Fulham Green 81-83 Fulham High Street London SW6 3JA United Kingdom 
Type of Sponsor  Other [Association of Neurological Member Societies] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya MR  All India Institute of Medical Sciences, New Delhi  Department of Neurology, Cardio Neuro center, All India Institute of Medical Sciences, New Delhi
South
DELHI 		 9958034273

dr.divyamr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS New Delhi Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HCWs will not receive any educational intervention. However, they will continue to work for patients with CNS TB.   HCWs will not receive any educational intervention. However, they will continue to work for patients with CNS TB.  
Intervention   Direct Educational Sessions and Training of Trainers  Neurologists from principal investigator’s institute (AIIMS, Delhi) will provide direct educational intervention to HCWs on a virtual platform. There will be 2 such educational sessions at 0 (E1) and 3 months (E2). Each session will be of 2-3 hours and include multiple didactic lectures (15-20 minutes duration) on CNS TB in the form of Microsoft power point presentations. The lectures will cover various aspects of CNS TB including magnitude of the problem, various clinical presentations, diagnosis and management of CNS TB with a focus on TBM. The HCWs will have the opportunity to ask questions and clear their doubts. To reinforce the knowledge, handouts or lecture notes will be provided after each session. The same HCWs will be followed up and the questionnaire will be re-administered after 2 weeks (T1) and 12 months (T2) of 2nd direct educational sessions. We will use vernacular language for communicating and preparing questionnaire and educational materials, including the handouts. Informed written consent will be obtained from all HCWs before participation. After completion of two direct educational sessions, we will identify 1-2 suitable persons, preferably medical officers (MOs), from the group of HCWs, who then can train the same group of HCWs at 6 monthly intervals. Whenever there is a felt need, extra direct sessions will be held. Complete anonymity of assessment data will be ensured and post-test scores of participants will not be disclosed at any point of time. The participants will have access to a specific WhatsApp group throughout the study period; the queries posted by HCW in relation to patient care will be addressed a neurologist within 48 hours. We will use separate training modules for MOs and rest of the HCWs.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  The participants will comprise all HCWs including primary care doctors from all systems of medicines, nurses and midwifes, health associates, Accredited Social Health Activists (ASHAs), and traditional practitioners 
 
ExclusionCriteria 
Details  NA 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of new cases of CNS TB detected or notified
 We will compare this outcome parameter over a 12 months prior to and 12 months after the full implementation of educational intervention. The number of new CNS TB cases in the intervention clusters during the same time frame will be compared with that of control clusters.
 		 Number of new cases of CNS TB detected or notified
 We will compare this outcome parameter over a 12 months prior to and 12 months after the full implementation of educational intervention. The number of new CNS TB cases in the intervention clusters during the same time frame will be compared with that of control clusters.
 
 
Secondary Outcome  
Outcome  TimePoints 
 Time from symptom onset to diagnosis of CNS TB
 Time from symptom onset to initiation of ATT
 Number of TBM patients presenting with advanced stage (stage 2 &3)

 		 [Time frame: over 12 months before and 12 months after the full implementation of educational intervention; any change in parameters will be compared between intervention & control clusters].  
 
Target Sample Size   Total Sample Size="915"
Sample Size from India="915" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Objective

Ø  The primary objective is to evaluate whether an educational intervention amongst HCWs can increase case detection and notification rates of CNS TB

Ø  The secondary objectives are to assess if increased awareness amongst HCWs

          Reduces the delay in diagnosis and initiation of ATT in patients with CNS TB

          Decreases the number of TBM patients presenting in advanced stages of the disease (BMRC stage 2 &3)

          Improves the existing knowledge and awareness of HCWs about CNS TB

   Methods

  Design: Cluster Randomized Control Trial

Duration: 2 years

Study population:

This study will be conducted in Ghaziabad district, Uttar Pradesh, India. Ghaziabad has high TB burden (Ref: https://reports.nikshay.in/Reports/TBNotification)] and is within 50KM of Principal Investigator’s institute.

In Ghaziabad, the District TB Center (DTC) is the nodal center for all TB activities. For effective TB care and control, there are 16 Tuberculosis units (TUs) under Ghaziabad DTC; each TU caters to around 2.5 Lakh populations. The TU comprises a designated Medical Officer- Tuberculosis Control (MO-TC) and one full-time Senior Treatment Supervisor (STS); one Senior TB Laboratory Supervisor (STLS) will continue to be in 5-lakh populations. The team of STS and STLS work under the administrative supervision of the MO-TC and the District TB Officer (DTO). In our study, the randomizing unit (cluster) will be one TU.

 BBaseline assessment

We will screen all EPTB cases notified (Ref Nikshay Portal, GOI) in the previous 1 year and those with CNS TB cases (Tuberculoma, TBM, spinal cord TB) will be identified.

A list of eligible participants with the level of training will be prepared. The participants will comprise all HCWs, including primary care doctors from all systems of medicines, nurses and midwifes, health associates, Accredited Social Health Activists (ASHAs), and traditional practitioners.

In the intervention arm, a self-administered questionnaire will assess the existing CNS TB related knowledge and practices of HCWs (T0).  A multi-pronged educational intervention will follow this.

Intervention:

§  Direct Educational Sessions and Training of Trainers:

Neurologists from the principal investigator’s institute (AIIMS, Delhi) will provide direct educational intervention to HCWs on a virtual platform. There will be 2 such educational sessions at 0 (E1) and 3 months (E2). Each session will be of 2-3 hours and include multiple didactic lectures (15-20 minutes duration) on CNS TB as Microsoft power point presentations. The lectures will cover various aspects of CNS TB, including magnitude of the problem, various clinical presentations, diagnosis and management of CNS TB with a focus on TBM. The HCWs can ask questions and clear their doubts. To reinforce the knowledge, handouts or lecture notes will be provided after each session. The same HCWs will be followed up and the questionnaire will be re-administered after 2 weeks (T1) and 12 months (T2) of 2nd direct educational sessions. We will use vernacular language for communicating and preparing questionnaire and educational materials, including the handouts. Informed written consent will be obtained from all HCWs before participation. After completion of two direct educational sessions, we will identify 1-2 suitable persons, preferably medical officers (MOs), from the group of HCWs, who then can train the same group of HCWs at 6 monthly intervals. Whenever there is a felt need, extra direct sessions will be held. Complete anonymity of assessment data will be ensured and post-test scores of participants will not be disclosed at any point in time. The participants will have access to a specific WhatsApp group throughout the study period; the queries posted by HCW in relation to patient care will be addressed by a neurologist within 48 hours. We will use separate training modules for MOs and rest of the HCWs.

Control Clusters: HCWs will not receive any educational intervention. However, they will continue to work for patients with CNS TB.

Outcomes

Primary outcome- Number of new cases of CNS TB detected or notified (We will compare this outcome parameter over a 12 months prior to and 12 months after the full implementation of educational intervention. The number of new CNS TB cases in the intervention clusters during the same time frame will be compared with that of control clusters.)

Secondary outcomes-

Time from symptom onset to diagnosis of CNS TB

Time from symptom onset to initiation of ATT

Number of TBM patients presenting with advanced stage (stage 2 &3) [Time frame: over 12 months before and 12 months after the full implementation of educational intervention; any change in parameters will be compared between intervention & control clusters].

Change in assessment scores secured by HCWs pre and post educational session [Time frame: at baseline (T0); 2 weeks (T1) and 12(T2) months after E2]

Change in DOTS utilization rate between intervention and control clusters

Utilization rate of specialist (Neurologist) opinion in intervention cluster

Randomization & Allocation concealment: Simple cluster randomization; 1:1 allocation. 

Blinding: Only outcome assessors will be blinded to the allocation.

Sample Size: 

The estimated population of Ghaziabad district is 4.68 million as per 2011 census India (http://www.census2011.co.in/district.php last accessed 21/7/21). The total number of TB cases notified (public and private combined) during the previous 1 year (1/7/2020-1/7/2021) from Ghaziabad was 12, 227 (Ref: Nikshay portal, National Tuberculosis Control Programme, Ministry of Health & Family Welfare, Government of India. https://nikshay.in/ last accessed 21/7/21). Considering 10% of all TB cases as CNS TB cases, we calculated the case notification rate of CNS TB for the previous year (1/7/2020-1/7/2021) as 26 per 100,000 populations.

The randomizing unit is 1 TU. We estimated sample size based on intra-cluster correlation coefficient (K) among the TU, cluster size, expected outcome and power with the unit of TU. After the educational intervention, we expect at least a 50% increase in CNS TB case detection and notification rate similar to the results from community intervention studies in PTB25, 30. Considering 80% power, 5% alpha error, and 50% increase in the CNS TB cases post-intervention (i.e. 39 cases per 100,000 population) we estimated the sample size as 416 cases (208 in each group). Each TU serves 1.5-2.5 lakh population in urban and rural areas. District Ghaziabad has 16 such TUs under the District TB Center (DTC) and on an average each TU caters to 2.5 lakh population. Considering the CNS TB as 26 per 1,00,000, we estimated the cluster size as 65 (per 2, 500,000 population/one TU). Further adjusting for design effect (we assumed design effect to be 2, as K was unknown), and calculating for 10% loss of follow-up, we estimated the final sample size as 915 CNS TB cases. To achieve this sample size, we will randomize 14 TU/clusters (7 TU in each arm). 

Study Flow

·     The proposal will be submitted to institute ethics committee for approval and permissions will be taken from the Chief Medical Officer (CMO), District TB officer (DTO) and other concerned health authorities of Ghaziabad before starting the study.

·       The study will be conducted in 3 phases (Please refer the project timeline below)

Phase 1: Data collection# (pre intervention)

Phase 2:  Educational Intervention

Phase 3:  Assessment (post intervention) & analysis

#Data collection: All patients receiving treatment for EPTB (Ref Nikshay dashboard, GOI) will be screened to identify those with CNS TB (TBM, tuberculoma with or without TBM and spinal cord TB), for a period 12 months before and 12 months following the intervention. The number and contact details of patients with EPTB collected from the Nikshay dashboard and databases of Ghaziabad DTC & TUs. We will also screen the registers/ database maintained at various TB treating facilities (public and private) within the district. After identifying the patients with CNS TB and getting informed consent data will be collected All available information including the demographic characteristics, type of CNS TB, duration of symptoms, time of onset of symptoms to diagnosis and initiation of ATT, stage/ grade at the diagnosis in patients with TBM, relevant investigations and treatment details will be entered to a pre-structured case record form. Similar method of data collection will be carried out in the control clusters as well. 

 
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