| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkarikalan82@gmail.com].
- 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.
- 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 “enable 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. |