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CTRI Number  CTRI/2024/05/066847 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   Assessing the usefulness of a psycho-social intervention for persons with TB and their caregivers 
Scientific Title of Study   An integrated psycho-social intervention to improve self- efficacy towards treatment uptake and infection prevention among patients and family caregivers. A multi- centric implementation research study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
073  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karikalan Nagarajan 
Designation  Scientist C 
Affiliation  ICMR-ICMR- National Institute for Research in Tuberculosis 
Address  No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031, INDIA

Chennai
TAMIL NADU
600031
India 
Phone  7299226582  
Fax    
Email  drkarikalan82@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Karikalan Nagarajan 
Designation  Scientist C 
Affiliation  ICMR-ICMR- National Institute for Research in Tuberculosis 
Address  No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031, INDIA

Chennai
TAMIL NADU
600031
India 
Phone  7299226582  
Fax    
Email  drkarikalan82@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karikalan Nagarajan 
Designation  Scientist C 
Affiliation  ICMR-ICMR- National Institute for Research in Tuberculosis 
Address  No.1, Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 031, INDIA

Chennai
TAMIL NADU
600031
India 
Phone  7299226582  
Fax    
Email  drkarikalan82@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAMESH PM  Government Hospital of Thoracic Medicine,  Superintendent Office, No77, Chennai - Theni Highway Sanatorium, Kadaperi, Chennai, Tamil Nadu 600047
Kancheepuram
TAMIL NADU 
9841859106

pmrmdchest2@gmail.com 
Dr N Karikalan  ICMR National Institute for Research in Tuberculosis  Department of Social and Behavioral Research,( First floor Clinic Building) No 1 Mayor Ramanathan Street Chetpet
Chennai
TAMIL NADU 
7299226582

drkarikalan82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-ICMR-National Institute for Research in Tuberculosis  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Self- efficacy driven psycho-social intervention   The intervention is a psycho-social support package for persons with TB and their caregivers. The intervention package consists of two individual counselling sessions which will be delivered during the first four weeks of treatment. Further two group sessions will be delivered between the fifth week of treatment and twenty fourth week of treatment. Interventions Sessions will take place for approximately 20 minutes during the treatment initiation period and subsequently will be increased to 4-5-60 minutes sessions for the group sessions at the middle and end of treatment. Individuals counselling sessions will impart information and counselling on TB treatment adherence, self-efficacy, nutrition intake, infection prevention, stigma redressal, risk behaviour avoidance caregivers roles and responsibilities. Group sessions will focus on participatory and game based activities to build treatment resilience, self-efficacy, problem solving skills, stress relaxation, inculcating positive attitude, treatment and nutrition goal setting and nurturing positive communication . A total of 4 sessions including two counselling and two group sessions will be provided at minimum.  
Comparator Agent  Standard of Psycho-Social Care for TB  For persons with TB and their caregivers, psycho -social care which is provided by the frontline health workers as part of TB program will be the standard of care. Standard of care will include brief Information Education and Counselling (IEC) given to persons with TB during treatment initiation till continuation in form of brief one to one interaction and delivering of pamphlets and posters. IEC will cover importance of TB treatment, duration, infection prevention and nutritional intake and others basic aspects of TB and its management. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult drug sensitive TB patients ( 18 years of age and above) who are initiated treatment for TB Patients with low treatment self-efficacy Adult DR-TB & MDR-TB patients on shorter regimen Caregivers of the adult DS TB and DR TB shorter regimen patients with low self-efficacy &  
 
ExclusionCriteria 
Details  Patients undergoing longer MDR-regimen
Younger than 18 years of age 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We will use patients self efficacy score and will estimate an adjusting for timing of assessment, with self-efficacy driven intervention arm as the exposure of interest.   Baseline Midline & Endline 
 
Secondary Outcome  
Outcome  TimePoints 
For secondary outcome we will use & patient’s adherence, loss to follow up rate & treatment outcome as reported by NTEP as a binary outcome  Baseline, 8th Week, 26th week. 
 
Target Sample Size   Total Sample Size="547"
Sample Size from India="547" 
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   Phase 2 
Date of First Enrollment (India)   15/05/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkarikalan82@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rationale/ gaps in existing knowledge,

 TB elimination goals to achieve 92% treatment success rate by 2025 requires improvement in the treatment uptake self-efficacy of patients to a substantial level.    Psycho -social interventions to improve the treatment self-efficacy and self-management skills to address the multi -dimensional challenges faced by   TB patients are needed to be integrated in the present TB care system

Objectives

To  adapt a self- efficacy driven  intervention     for   improving the  treatment self-efficacy  of TB patients  and family care givers under NTEP program   and to evaluate  its efficacy in comparison to the standard of care  on primary   outcomes: i. improved  TB  treatment self-efficacy  and  secondary outcomes i. improved medication adherence  ii decreased TB stigma & iii. improved infection controls self-management practices 

 Novelty

The proposed intervention is based on self-efficacy constructs in which the patients and caregivers are intervened to   â€œenable them to execute their own courses of actions, behaviors and self-management skills to effectively deal with challenges and needs of TB disease and treatment.   The elements of the proposed intervention  is    derived from the insights of positively deviant TB patients and their caregivers  who had coped up with TB in the best possible way and have exhibited maximum  self-efficacy. Thus the acceptance and adaptation of proposed intervention is hypothesized as more beneficial as compared to the health care provider driven vertical interventions

 Methods

A multi centric hybrid mixed method implementation design  to adapt and evaluate implementation feasibility and efficacy  of delivering a self- efficacy driven intervention   using an implementation research approach.

  

Expected outcome.

The proposed self-efficacy driven  intervention of proven efficacious will be the first integrated, theory-driven and evidence-based psycho-social intervention for TB patient that may positively impact self-efficacy and also acceptance and uptake of treatment, self-care and underlying psycho-social issues in a holistic  way. Evidences of efficacy from this study will lead to scaling up of self-efficacy interventions in a pragmatic way under NTEP program which could improve treatment services and outcomes for TB patients in India.

 


 
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