跳至主要内容
临床试验/NCT05697822
NCT05697822尚未招募不适用

The Effect of a Patient-involved Mobile Phone and Cloud-based Electronic Contact and Recording System on Institutional Deliveries and Other Maternal and Infant Health Outcomes in Rural Nepal: A Cluster Randomized Controlled Trial

Amit Arjyal1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
360
试验地点
1
主要终点
Institutional Delivery Rate

研究概览

简要总结

The goal of this cluster randomized controlled trial is to study the effect of a mobile-phone based application used by pregnant women on maternal and newborn health indicators. The main objective is to compare the rates of institutional deliveries in the intervention and control arms. Ancillary objectives are to compare the birth-preparedness and complication readiness parameters, severe maternal morbidity rates and neonatal adverse outcomes rates in the two arms. The participants are pregnant women.

In the intervention arm pregnant women will be given a smart mobile phone with an application that they will use to input information related to their health. This information can be shared with their healthcare workers. The healthcare workers will also be able to access all the health-related details of the pregnant women and mothers under their care by accessing this app in their mobile phones and be in touch with their patients through the mobile phone application.

The control arm will adhere to existing practices of pregnant woman and health worker communication without the use of a smart mobile phone with an existing application. Records related to the pregnant woman will be kept in paper-based forms as is the usual norm.

The investigators will compare the intervention arm and the control arm to see if there are differences in the rates of the outcomes.

详细描述

Improving maternal and newborn health requires innovative approaches that are flexible and cater to the need of the end-user, the patient. In the recent years telecommunication services that have seamlessly entered the lives of the both providers and receivers of health care both in developing and underdeveloped nations and have been a fertile ground for such innovations. There has been rapid growth of the use of mobile phone technologies (mobile health/mHealth) in low and middle income countries (LMICs). These function predominantly in the areas of client education and behavior change communication, registries and vital event tracking, data collection and reporting, provider to provider communication and electronic health records. In our setting as well, there has been successful implementation of the electronic medical records at health facility level and community based institutions and mobile health applications for the community level health providers. The major users of these digital platforms are service providers rather than patients.

However, using electronic medical records that a pregnant woman and/or a mother can fill up at home may provide more opportunities to identify risks and practices that reflect the real situation better than surveys or registries which rely on recall. So far, there is no such intervention in our setting to incorporate the users as the direct data keepers in the health system. Also, there is lack of evidence on the benefit of such applications for maternal and child health. Therefore, we are conducting a cluster randomized controlled trial on user based advanced data systems to improve health in early life in rural Nepal.

The intervention will be evaluated using a cluster randomized controlled trial design. The rationale is that the intervention is applied to the entire community and individual randomization is not feasible due to contamination. A rural municipality ward, the lowest administrative level in Nepal, will be randomized into intervention or control cluster. Because of the nature of the intervention, allocation is not masked. This project will be carried out in three rural municipalities of southern Lalitpur District, namely Konjyosom, Mahankal and Bagmati Rural Municipalities. Eighteen wards or clusters, nine(9) in the intervention arm and nine(9) in the control arm are included.

The investigators will implement the mobile-phone based system in the intervention clusters while non-intervention clusters will have the currently existing health care data management and patient contact system.

In the intervention arm, a data-system with mobile phone-based application will be deployed. The application will be used by pregnant women to obtain useful information related to their pregnancy and also enter vital information related to their health. The database will be accessible to healthcare providers at various levels of our health system such as health posts, and district or municipal level hospitals. The healthcare providers will also be able to access the data and enter clinical information when the pregnant women go to the health centre. The application will also be used during the time of labour and after delivery to record information about the post-partum state and infancy of the newborn child.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

This study is open-label as both the participants and study team members will know whether they are in the intervention or control arms. However, the outcomes related to morbidity will be assessed by a masked assessor.

The outcomes such as severe maternal morbidity (SMM), and neonatal adverse outcomes(NAO) will be assessed by a study technical committee member who do not have any knowledge about the arm in which the study participant is allocated. The information about the study arm will be removed from the database when this assessment is being made. Although the criteria for SMM and NAO are generally objective, there might be some need for judgement on the part of the assessors hence masking will avoid biased assessment of outcome.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant with less than 20 weeks of gestation
  • Usual resident of the study ward at the time of enrollment (A woman is considered a usual resident if the house she normally lives is in, is in that ward)
  • Provides informed written consent

排除标准

  • Temporary resident of the ward
  • Cannot read and write
  • Cannot use a mobile phone
  • Has any disability, such as blindness, that prevents the use of mobile phone

结局指标

主要结局

Institutional Delivery Rate

时间窗: At the time of delivery

Delivery at a birthing center, health post, primary health care center, or any hospital

次要结局

  • Severe Maternal Morbidity (SMM) Rate(Upto 42 days after delivery)
  • Birth Preparedness and Complication Readiness Index Score(Upto 42 days after delivery)
  • Neonatal Adverse Outcome (NAO) Rate(Upto 42 days after delivery)
  • Maternal Mortality Indicator(Upto 42 days after delivery)
  • Newborn Mortality Indicators(Upto 42 days after delivery)

研究者

发起方
Amit Arjyal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amit Arjyal

Assistant Professor

Patan Academy of Health Sciences

研究点 (1)

Loading locations...

相似试验

Using Advanced Data Systems to Improve Health in... | 临床试验