Clinical trial NCT05697822: Using Advanced Data Systems to Improve Health in Early Life in Rural Nepal
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Health
Infant Health
Institutional Delivery
Birth Preparedness and Complication Readiness
Severe Maternal Morbidity
Neonatal Adverse Outcome
Keywords: electronic health database
maternal health
infant health
institutional delivery
birth preparedness and complication readiness
severe maternal morbidity
neonatal adverse outcome
mobile health
mHealth
Lead sponsor: Patan Academy of Health Sciences
Sponsor class: OTHER
Collaborators: name: Bagmati Rural Municipality, Lalitpur, Nepal
name: Konjyosom Rural Municipality, Lalitpur, Nepal
name: Mahankal Rural Municipality, Lalitpur, Nepal
name: School of Health Sciences, Purbanchal University, Nepal
First posted: 2023-01-26
Enrollment: 360
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Institutional Delivery Rate
timeFrame: At the time of delivery
Secondary outcomes:
measure: Birth Preparedness and Complication Readiness Index Score
timeFrame: Upto 42 days after delivery
measure: Severe Maternal Morbidity (SMM) Rate
timeFrame: Upto 42 days after delivery
measure: Neonatal Adverse Outcome (NAO) Rate
timeFrame: Upto 42 days after delivery
measure: Newborn Mortality Indicators
timeFrame: Upto 42 days after delivery
measure: Maternal Mortality Indicator
timeFrame: Upto 42 days after delivery
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Patan Academy of Health Sciences
state: Bagmati
Study officials:
affiliation: Patan Academy of Health Sciences
name: Ranjan P Devbhandari, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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