Development and Evaluation of a Culturally Tailored Digital Decision Support System (DSS) for Early Screening, Medical Nutrition Therapy, and Integrated Management of GDM and HDP in Primary Care Settings in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of women diagnosed with GDM by 20 weeks gestational age using OGTT
研究概览
简要总结
Title: Digital Decision Support System for Improving Management of Gestational Diabetes and Hypertensive Disorders in Pregnancy
Background / Objective: Gestational Diabetes Mellitus (GDM) and Hypertensive Disorders of Pregnancy (HDP) are common medical conditions that increase risks for both mother and child—including preterm birth, stillbirth, and long-term health problems like type 2 diabetes and heart disease. Although India has national guidelines for screening and managing these conditions, many primary health centers lack resources like trained nutritionists or structured dietary advice. As a result, many women do not receive timely, personalized care. This project aims to address these gaps by developing a Digital Decision Support System (DSS) that helps frontline health workers (Medical Officers, ANMs, ASHAs) screen, counsel, and manage GDM and HDP effectively using a culturally tailored, protocol-based approach.
Novelty: This will be the first study in India to develop and evaluate a real-time DSS that integrates region-specific Medical Nutrition Therapy (MNT), structured care pathways, and digital prompts for health workers to manage both GDM and HDP.
Hypothesis / Research Question: Can integrating a culturally adapted, protocol-driven DSS at the PHC level improve early screening, initiation of Medical Nutrition Therapy, and follow-up management for GDM and HDP?
Study Objectives:
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To develop and evaluate a culturally tailored DSS for MNT and care of GDM and HDP.
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To assess its feasibility and acceptability among frontline health providers.
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To measure improvements in adherence to national protocols and patient outcomes.
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To integrate the DSS with existing digital systems like the RCH Portal.
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To evaluate improvement in patient knowledge and treatment continuity.
Methods: A mixed-methods implementation study will be conducted across PHCs in India. The DSS will be co-designed with stakeholders, piloted, and evaluated for effectiveness using quantitative and qualitative methods.
Expected Outcome: The DSS is expected to improve timely identification, personalized dietary counseling, and better continuity of care for women with GDM and HDP, while reducing over-referral and empowering frontline health workers.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women less than or equal to 20 weeks gestation at the time of ANC registration at study PHC and CHC Willing to provide informed consent Plan to remain in the catchment area for the duration of pregnancy and postpartum.
排除标准
- •Women with pre-existing diabetes or chronic hypertension diagnosed prior to pregnancy, Referred or transferred out before initial assessment Known diagnosis of diabetes mellitus prior to current screening (for pregnancy-related studies: pre-existing type 1 or type 2 diabetes).
- •Severe comorbid illness limiting participation (e.g., advanced chronic kidney disease, severe cardiac disease).
- •Unable to provide informed consent.
- •Planning to move away from study area during the study period.
结局指标
主要结局
Proportion of women diagnosed with GDM by 20 weeks gestational age using OGTT
时间窗: At baseline, midline at the time of delivery and postpartum 6 weeks and 6 months.
次要结局
- Neonatal Outcomes:
- Glycemic Control
- System and Provider Outcomes:(Fidelity: DSS usage fidelity (percentage of prompts followed).)
- Qualitative Outcomes:
研究者
Dr Teena Dasi
ICMR NIN, HYDERABAD