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CTRI Number  CTRI/2024/04/065209 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Effect of supportive interventions in improving treatment outcomes among new Tuberculosis patients in Puducherry 
Scientific Title of Study   Effect of reinforced supportive interventions on treatment outcomes among newly diagnosed Pulmonary Tuberculosis patients in Puducherry - An Interventional Study 
Trial Acronym  ReSIT 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vignesh 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  No. 308, Department of Community Medicine, Pondicherry Institute of Medical Sciences, Ganapathichettikulam, Kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  8870892262  
Fax    
Email  vigneshdhakshina@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vignesh 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  No. 308, Department of Community Medicine, Pondicherry Institute of Medical Sciences, Ganapathichettikulam, Kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  8870892262  
Fax    
Email  vigneshdhakshina@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Velavan 
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  No. 310, Department of Community Medicine, Pondicherry Institute of Medical Sciences, Ganapathichettikulam, Kalapet

Pondicherry
PONDICHERRY
605014
India 
Phone  9894078814  
Fax    
Email  velu.anand13@gmail.com  
 
Source of Monetary or Material Support  
No. 68, State TB office, Ambour Salai, Puducherry, India 605001 
 
Primary Sponsor  
Name  State TB Office 
Address  No. 68, State TB office,Ambour Salai, Puducherry, India 605001 
Type of Sponsor  Government funding agency 
 
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 Vignesh  Pondicherry Institute of Medical Sciences  No. 308, Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry.
Pondicherry
PONDICHERRY 		 8870892262

vigneshdhakshina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatment under NTEP  Conventional Anti tubercular drugs with existing support by the government 
Intervention  Reinforced supportive intervention along with anti-tubercular drugs for 6 months  Counselling, Diet chart, Facilitating deaddiction, Facilitating comorbidity, Adverse effect active monitoring, Follow up for treatment adherence along with anti-tubercular drugs for 6 month duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Individuals who are 18 years and above and newly diagnosed as confirmed Pulmonary Tuberculosis case will be included 
 
ExclusionCriteria 
Details  Extra pulmonary cases of TB, very sick patients, Drug resistant TB, HIV-TB 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Favourable: Cured, Treatment completed.
Unfavourable: Lost to follow up, Deaths, Non-adherence, Treatment failure.
 		 6 months from initiation of ATT 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the Behavioral risk factors: Alcohol consumption, Smoking, Diet, Physical activity, adherence to treatment, comorbidity management.
 		 6 months from initiation of ATT 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 01/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Title of the dissertation:

Effect of reinforced supportive interventions on treatment outcomes among newly diagnosed Pulmonary Tuberculosis patients in Puducherry - An Interventional study

Introduction

 Tuberculosis (TB) is an infectious disease caused by the bacterium Mycobacterium tuberculosis, primarily affecting the lungs but capable of affecting other organs as well. Common symptoms include a persistent cough with blood-tinged mucus, fever, night sweats, and unexplained weight loss. The transmission of TB occurs through the air when individuals with active TB in their lungs cough, speak, spit, or sneeze. Diagnosis of active TB involves chest X-rays, microscopic examination of sputum, and the culture of body fluids.  On the other hand, latent TB can be diagnosed using the tuberculin skin test (TST) or blood tests. Prevention strategies include screening individuals at high risk, early detection, treatment of active cases, and vaccination with the Bacillus Calmette-Guérin (BCG) vaccine. Treatment for TB requires the use of multiple antibiotics over an extended period. However, the emergence of antibiotic resistance, particularly in the form of multiple drug-resistant tuberculosis (MDR-TB), poses a significant challenge. Non-adherence to anti-tuberculosis medication is a major risk factor for poor treatment outcomes. In summary, addressing tuberculosis involves a multifaceted approach, including prevention through vaccination, early detection, and treatment of both active and latent cases. The increasing prevalence of antibiotic resistance underscores the importance of adherence to medication regimens for successful outcomes in TB treatment. 

a. Problem statement

 Burden:

Global scenario of Tuberculosis:

In 2018, approximately 25% of the global population was estimated to harbor a latent tuberculosis (TB) infection. New TB infections were occurring in about 1% of the population annually. In 2020, an estimated 10 million individuals developed active TB, leading to 1.5 million deaths and ranking TB as the second most common cause of death from an infectious disease, following COVID-19. As of 2018, the majority of TB cases were concentrated in South-East Asia (44%), Africa (24%), and the Western Pacific (18%). Over 50% of cases were diagnosed in seven countries: India (27%), China (9%), Indonesia (8%), the Philippines (6%), Pakistan (6%), Nigeria (4%), and Bangladesh (4%). By 2021, there was a decreasing trend in the annual number of new TB cases, declining by approximately 2% each year. TB prevalence varies globally, with about 80% of individuals in many Asian and African countries testing positive for TB, whereas only 5–10% of individuals in the United States test positive using the tuberculin test. TB has been a persistent presence in human populations since ancient times.

Indian scenario of Tuberculosis:

As per the Global TB Report 2021, the estimated incidence of all forms of TB in India for the year 2020 was 188 per 100,000 population (129-257 per 100,000 population). Accordingly, 2021 witnessed a 19% increase from the previous year in TB patients notification - the total number of incident TB patients (new and relapse) notified during 2021 were 19,33,381 as opposed to that of 16,28,161 in 2020.

b. Rationale

Tuberculosis treatment outcome in Puducherry for new cases (Success rate of new cases during 2016 is 93%) and retreatment cases (Success rate of retreatment cases during 2016 is 72%). Inspite of newer initiatives, treatment outcome has not changed grossly. Hence this study is done to find the effect of selected tailored interventions in improving outcome.

c.     Novelty

This will be first interventional study in Puducherry to find the changes in outcome due to selected need-based interventions on patients diagnosed with Pulmonary tuberculosis.

d.     Expected outcome and application:

Increase in proportion of favourable treatment outcomes of patients with anti-tubercular therapy + selected supportive treatment compared to the patients with conventional anti-tubercular therapy without selected supportive treatment

Objective:

Primary objective:          

To measure the effect of selected supportive interventions along with conventional treatment in comparison to conventional treatment only on treatment outcomes among newly diagnosed pulmonary tuberculosis patients in Puducherry.

To find the demographic, clinical and behavioral risk factors of tuberculosis associated with treatment outcomes among these newly diagnosed Pulmonary Tuberculosis patients.

Materials and Methods:

7.1           Study settings: Puducherry district has 4 Tuberculosis units. 1 Tuberculosis Unit of Puducherry district which is in our Medical College DMC will be included for intervention and other 1 Tuberculosis unit randomly selected will act as control group.

                   Study design: An interventional study. (Non-Randomized Controlled Trial)

  Study period and duration: The study will be conducted between March 2024 and       February 2026 (24 months).

  Study participants: All newly diagnosed Pulmonary Tuberculosis patients who are residence of Puducherry from the respective Tuberculosis units will form the study subjects

Inclusion criteria: Individuals who are 18 years and above and newly diagnosed as confirmed Pulmonary Tuberculosis case will be included.

Exclusion criteria: Extra pulmonary cases of TB, very sick patients, Drug resistant TB, HIV-TB.

7.5           Description of study groups (for comparative/analytical studies only):

Intervention group and Control group

Adult Pulmonary Tuberculosis patients who are 18 years and above and residence of Puducherry will be recruited from 1 TB unit for intervention. Similarly, Adult Pulmonary Tuberculosis patients who are 18 years and above will be recruited as controls in another Tuberculosis unit.

 Sample size and method of calculation with reference to study on which it is based:

Sample size was calculated based on the study by Raval et al.,(10) with the proportion of adherence rate of intervention group as 0.857 and control group as 0.67, with 5% level of significance and 80% power the required sample size is 77 per group. Considering the attrition rate of 10%, the final required sample is rounded to 85 per group. (Calculated using nMaster 2.0)

 Sampling technique and method of recruitment:

The study will be conducted in 2 Tuberculosis Units in the district of Puducherry. Newly diagnosed Pulmonary Tuberculosis patients 18 years and above for intervention who are eligible under inclusion criteria will be recruited consecutively from 1 Tuberculosis unit till the desired sample size is achieved. Similarly, newly diagnosed patients who are 18 years and above who are eligible under inclusion criteria will be recruited as controls in another Tuberculosis unit.

 Method of randomization (for RCT only):  Not applicable.

Study tools:

A structured questionnaire to capture the demographic, clinical and behavioural risk factors will be used. Data extraction form to capture the details of the study participant from treatment card including treatment outcome.

A diet chart consisting of recommended food items for consumption and model menu will be given to all study participants in the intervention group.

A pamphlet will be given during the counselling indicating the spread, diagnosis, symptoms, complications and treatment available for these patients.

Study variables:

·       Socio-demographic details: The details regarding the name, age, sex, address, contact details, education, occupation and per capita income of the study participants.

·       Behavioral risk factors: Alcohol history, Smoking history, Diet, Physical activity

·       Clinical factors: Initial symptoms, Side effect or Adverse events, Height, Weight, BMI, Comorbidities

·       Monthly treatment adherence and follow up

·       Treatment outcomes

o   Favorable: Cured, Treatment completed

o   Unfavorable: Lost to follow up, Deaths, Non-adherence, Treatment failure

 Data collection and measurements:

Patient related details in both groups will be extracted from the treatment card.

Height: The height of the subjects will be measured by a Stadiometer with an accuracy of 2 mm.

Weight: The weight of the subjects will be measured by digital weighing scale with an accuracy of 100 gm

Data will be collected by the candidate by personal visit at home/Primary Health Centre during the period of 24 months from March 2024 to February 2026 at the selected Tuberculosis unit or Local Primary Health Centre using a standardised questionnaire.

Health education will focus on selected supportive interventions as follows:

                                               i.     Counselling for all Tuberculosis patients and family members/ caretakers

                                             ii.     Dietary interventions for all Tuberculosis patients

                                           iii.     Facilitating deaddiction counselling for patients if required (alcohol, smoking)

                                            iv.     Adverse effect management/ monitoring for all Tuberculosis patients

                                             v.     Facilitating Comorbidity management for patients with comorbidities

                                            vi.     Reminders for treatment adherence on monthly basis via SMS and Phone Call 

In Individuals who are newly diagnosed as confirmed Tuberculosis case in selected Primary Health Centers in district of Puducherry during March 2024 to February 2026 (24 months)

Description of study procedure:

            Recruitment of the study participants based on the inclusion criteria and made as intervention group and control group. Data is extracted from both the group from the treatment card of the respective Tuberculosis unit. At first visit a structured questionnaire is administered to the interventional group to find the baseline characteristics and along with it the counselling about the disease, adverse effect sensitisation, facilitating comorbidity management and facilitating deaddiction counselling. A second visit is done at the end of Intensive phase or initial month of Continuous phase (2 to 3 months) were treatment adherence, comorbidity control, adverse effect monitoring/ management is done. Monthly follow-up via SMS and Phone call is done until the end of regime (6 months). Post regime data is extracted from the treatment card of both intervention group and control group Tuberculosis units and compared for favourable and unfavourable treatment outcomes.

Statistical analysis plan:

 The data will be entered in MS Excel and analyzed using Statistical Package for the Social Sciences for Windows (SPSS Inc., Chicago, Illinois, USA) 26th version. Prevalence data will be presented in the form of numbers, percentages and proportions in tables and figures. To compare the difference in proportions of two groups, the chi-square test will be used. Logistic regression will be used to find the risk factors associated with favorable and unfavorable outcome in intervention group.

Quality Control of Data: Data will be collected and entered by the PG himself.            Random check of data will be done by the Guides and Co Guides.

Ethical considerations:

While carrying out the study ensure the following:

  • I undertake to ensure the following as per the ICMR and other applicable guidelines:
  • All participants will be explained in the language comprehensible to them, the details of the study and level of risk/ benefit associated with it.
  • Voluntariness to participate and Consent/Assent to be obtained
  • The study will be performed as per the approved protocol only.
  • If any deviation is warranted, the same will be presented to the ethical committee and permission will be sought.
  • Waiver of consent is requested to access the treatment details of patients in control group.
 
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