| CTRI Number |
CTRI/2025/11/097797 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Can a Storybook Help TB Patients with Other Diseases? |
|
Scientific Title of Study
|
Evaluating the effectiveness of a health literacy Intervention for TB patients having multimorbidity: A mixed-method study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debdutta Bhattacharya |
| Designation |
Scientist-E |
| Affiliation |
ICMR - Regional Medical Research Centre Bhubaneswar |
| Address |
Room NO-10, Department Of Microbiology,ICMR - Regional Medical Research Centre, Chandrasekharpur,Bhubaneswar
Khordha
ORISSA
751023
India |
| Phone |
09886126077 |
| Fax |
|
| Email |
drdebdutta.bhattacharya@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debdutta Bhattacharya |
| Designation |
Scientist-E |
| Affiliation |
ICMR - Regional Medical Research Centre Bhubaneswar |
| Address |
Room NO-10, Department Of Microbiology,ICMR - Regional Medical Research Centre, Chandrasekharpur,Bhubaneswar
Khordha
ORISSA
751023
India |
| Phone |
09886126077 |
| Fax |
|
| Email |
drdebdutta.bhattacharya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debdutta Bhattacharya |
| Designation |
Scientist-E |
| Affiliation |
ICMR - Regional Medical Research Centre Bhubaneswar |
| Address |
Room NO-10, Department Of Microbiology,ICMR - Regional Medical Research Centre, Chandrasekharpur,Bhubaneswar
Khordha
ORISSA
751023
India |
| Phone |
09886126077 |
| Fax |
|
| Email |
drdebdutta.bhattacharya@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ICMR-Regional Medical Research Centre, Bhubaneswar. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research Headquarters |
| Address |
AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanveer Rehman |
ICMR Regional Medical Research Centre, Bhubaneswar |
Room no-57, Department of Public Health, ICMR Regional Medical Research Centre, Nalco Nagar, Chandrasekharpur, Pin- 751023,Bhubaneswar
Khordha
ORISSA |
8336922482
drtanveerrehman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR- REGIONAL MEDICAL RESEARCH CENTRE, BHUBANESWAR ACADEMIC ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A157||Primary respiratory tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health literacy fotonovelas |
story-based fotonovelas in Odia and Hindi developed through community-based participatory action. The health literacy fotonovelas intervention will be delivered to enrolled TB patients with multimorbidity, and each participant will be followed up for a total duration of 6 months (baseline, 3 months, and 6 months). Thus, the intervention period per participant is 6 months. |
| Comparator Agent |
There is no separate control group. |
The study will focus on the feasibility and usefulness of the fotonovelas program in routine TB care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed TB patients having multimorbidity and those who give written informed consent irrespective of the drug sensitivity status. |
|
| ExclusionCriteria |
| Details |
Seriously ill/moribund TB patients and those who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceptability, adoption, and appropriateness of the fotonovelas intervention (patients and providers). |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Health literacy (measured using HLQ-9).
Medication adherence.
Self-management practices. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/11/2025 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
The project involves developing and pilot-testing a health literacy intervention in the form of fotonovelas (photo-based storytelling booklets) for TB patients with multimorbidity in Odisha, India. Design & Setting:
A quasi-experimental pre–post study will be conducted across six clusters (Tuberculin Units) in Khurda district. About 120 adult TB patients with multimorbidity (TB with HIV/Hepatitis or TB with DM/Hypertension) will be recruited. Intervention: The fotonovelas will be developed through community-based participatory action research, culturally adapted, and validated for readability, credibility, and relevance. The materials will depict patient-centered stories on treatment adherence, self-management, and navigating healthcare. Delivery will be through trained healthcare workers (nurses, treatment supervisors, DOT providers, doctors) at the Tuberculin Units. Comparator:
No separate control group is included; instead, feasibility and effectiveness will be evaluated within the intervention clusters. Outcomes: Primary outcomes: feasibility, acceptability, adoption, and appropriateness of the intervention (from both patients’ and providers’ perspectives). Secondary outcomes: medication adherence, self-management, healthcare utilization and expenditure, quality of life, and self-rated health across baseline, 3-month, and 6-month follow-up. Sample & Evaluation: 20 participants per cluster, total of 120. Data will be collected using electronic tools (ODK) with both quantitative and qualitative methods. Evaluation will follow the Consolidated Framework for Implementation Research (CFIR) and a traffic light system (green/amber/red) to decide progression to a larger trial. Reporting will adhere to CONSORT guidelines. Expected Contribution:
This will be the first standardized health literacy intervention for TB multimorbidity in India, potentially scalable through Health and Wellness Centers to improve integrated TB care and reduce inequities. |