跳至主要内容
临床试验/CTRI/2025/11/097797
CTRI/2025/11/097797尚未招募2 期

Evaluating the effectiveness of a health literacy Intervention for TB patients having multimorbidity: A mixed-method study.

Indian Council of Medical Research Headquarters1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Acceptability, adoption, and appropriateness of the fotonovelas intervention (patients and providers).

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • newly diagnosed TB patients having multimorbidity and those who give written informed consent irrespective of the drug sensitivity status.

排除标准

  • Seriously ill/moribund TB patients and those who are not willing to participate in the study.

结局指标

主要结局

Acceptability, adoption, and appropriateness of the fotonovelas intervention (patients and providers).

时间窗: 6 months

次要结局

  • Health literacy (measured using HLQ-9).

研究者

发起方
Indian Council of Medical Research Headquarters
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Debdutta Bhattacharya

ICMR - Regional Medical Research Centre Bhubaneswar

研究点 (1)

Loading locations...

相似试验

Can a Storybook Help TB Patients with Other Diseases? | 临床试验