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NCT05697822 | Not yet recruiting | Maternal Health


Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal
Sponsor:

Amit Arjyal

Information provided by (Responsible Party):

Amit Arjyal

Brief Summary:

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.

Condition or disease

Maternal Health

Infant Health

Institutional Delivery

Birth Preparedness and Complication Readiness

Severe Maternal Morbidity

Neonatal Adverse Outcome

Intervention/treatment

Mobile Phone and Cloud-based Electronic Contact and Recording System

Phase

Not Applicable

Detailed Description:

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. The investigators will carry out a prospective follow-up in which all institutional/home deliveries, birth preparedness and complication readiness parameters, severe maternal morbidity, neonatal adverse outcomes, stillbirths, neonatal and later infant deaths and deaths of women in the study population are recorded through interviews conducted during the recruitment, at 6-9 months of pregnancy, right after delivery and at 42 days after delivery. This study is led by Patan Academy of Health Sciences, Lalitpur, Nepal in collaboration with Purbanchal University, Lalitpur, Nepal. The investigators have received a grant from University Grants Commission, Nepal for this project. The investigators have signed a Memorandum of Understanding with the three rural municipalities of southern Lalitpur namely, Bagmati, Konjyosom and Mahankal Rural Municipalities and plan to work in close liaison with the Ministry of Health, Department of Health Services, Health Office for Lalitpur District and Government Integrated Data centre (GIDC) to undertake this project.}}

Study Type : Interventional
Estimated Enrollment : 360 participants
Masking : Single
Masking Description : 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.
Primary Purpose : Health Services Research
Official Title : 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
Actual Study Start Date : March 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024
Arm Intervention/treatment

Experimental: Mobile Phone and Cloud-based Electronic Contact and Recording System

In this arm pregnant women will be given a smart mobile-phone with an application installed which will have their detailed health-related information. They will be able to use this application to input their daily symptoms. This will also contain results of examinations or investigations that they have undergone in a clinic. All this information will be stored in a cloud and the healthcare worker at the local health post will also be able to access this information in their mobile phone and keep track of the pregnant women under their care. In the event of a concerning symptom, the health worker will be flagged. The health coordinators in the rural municipality will also be able to keep track of the pregnant women in their area through a cloud-based database.

No Intervention: Usual Standard of Care Arm

Pregnant women will visit the health posts or hospitals for antenatal checks routinely as advised. Their records will be kept in paper-based forms and registers. They will not be tracked regularly by their healthcare provider by electronic means. Their daily symptoms will not be recorded anywhere. They will still be able to contact their healthcare providers or visit the health centers if necessary. They will not have a personal electronic health record. No one will keep active track of the pregnant women through electronic means.

Ages Eligible for Study:
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal

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Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal

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Locations


Not yet recruiting

Nepal, Bagmati

Patan Academy of Health Sciences

Lalitpur, Bagmati, Nepal,

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