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临床试验/CTRI/2025/08/092973
CTRI/2025/08/092973招募中不适用

An Artificial-Intelligence-Based Intervention To Improve Iron Folic Acid (IFA) Adherence Among Anemic Women In An Urban Community: A Randomized Control Trial In South- East Delhi

Hamdard Institute of Medical Sciences and Research HIMSR1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
280
试验地点
1
主要终点
1.Improvement in hemoglobin levels (pre-post comparison)

研究概览

简要总结

This Randomized Controlled Trial evaluates the effectiveness of an AI-based monitoring package (IIC-MP) in improving adherence to Iron and Folic Acid (IFA) supplementation among anemic, non-pregnant, and non-lactating women (18–49 years) in South-East Delhi. The intervention group receives AI-driven WhatsApp chatbot reminders, IVR calls, and educational videos, while the control group receives routine care under the Anemia Mukt Bharat program. The study measures improvements in IFA compliance and hemoglobin levels over the intervention period to determine if digital monitoring significantly outperforms standard care

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 49.00 Year(s)(—)
性别
Female

入选标准

  • Non pregnant or non lactating women in reproductive age (18 years or above) with mild to moderate anemia.
  • Women residing in the study area since the last 6 months and are not planning to move out from the study area in the next 6 months.
  • Women having access to mobile phones with internet services.
  • Women willing to participate in the study and giving written informed consent.

排除标准

  • 1.Women with severe anemia.
  • 2.Women with a history of repeated blood transfusion, hemolytic anemia, chronic diarrhoea, stomach ulcer, heart surgery/prosthetic valves, cancer, tuberculosis, CKD, thalassemia, IBD, Liver disorders, colon cancers.
  • 3.Women currently undergoing medical therapy known to interfere with iron or folic acid absorption/metabolism including tetracyclines, anticoagulants, proton pump inhibitors, antiepileptics, or immunosuppressants etc.
  • will be excluded to ensure outcome validity and participant safety.
  • 4.Women who are already benefiting from existing nutritional supplementation health schemes/on treatment from any medical facility.
  • 5.Women who are unable to understand and provide written informed consent will be excluded from the study.

结局指标

主要结局

1.Improvement in hemoglobin levels (pre-post comparison)

时间窗: 1.Baseline (Week 0) and Endline (Week 24 / 6 months) 2.Baseline (Week 0) and Endline (Week 24 / 6 months) 3.Daily monitoring over 6 months; final assessment at Week 24 (6 months)

2.Reduction in prevalence of anemia (intervention vs control)

时间窗: 1.Baseline (Week 0) and Endline (Week 24 / 6 months) 2.Baseline (Week 0) and Endline (Week 24 / 6 months) 3.Daily monitoring over 6 months; final assessment at Week 24 (6 months)

3.Improved compliance of IFA intake (intervention vs control)

时间窗: 1.Baseline (Week 0) and Endline (Week 24 / 6 months) 2.Baseline (Week 0) and Endline (Week 24 / 6 months) 3.Daily monitoring over 6 months; final assessment at Week 24 (6 months)

次要结局

  • Adherence to a full intervention package (counseling, reporting, diary, etc.)

研究者

发起方
Hamdard Institute of Medical Sciences and Research HIMSR
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shivani Rawat

Hamdard Institute of Medical Sciences and Research (HIMSR)

研究点 (1)

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