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

NCT05697822 | Unknown DMC

• 2 other identifiers: 2-2022CTSR - 77/78 - 4
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Institutional Delivery Rate

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

  At the time of delivery

Secondary Outcomes (5)

• Birth Preparedness and Complication Readiness Index Score

  Upto 42 days after delivery

• Severe Maternal Morbidity (SMM) Rate

  Upto 42 days after delivery

• Neonatal Adverse Outcome (NAO) Rate

  Upto 42 days after delivery

• Newborn Mortality Indicators

  Upto 42 days after delivery

• Maternal Mortality Indicator

  Upto 42 days after delivery

Study Arms (2)

Mobile Phone and Cloud-based Electronic Contact and Recording System

EXPERIMENTAL

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.

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

Usual Standard of Care Arm

NO INTERVENTION

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.

Interventions

Mobile Phone and Cloud-based Electronic Contact and Recording System OTHER

A mobile phone application has been developed which is intended to be used by pregnant women and their healthcare workers. A pregnant woman can get registered in this app and enter information and data related to their health and current pregnancy. Their health worker at their health post can access this information on their mobile phone too. The pregnant woman can also input her daily symptom on this app. She can also input and/or access information on examination and tests that have been carried out. If a concerning symptom or event has been entered by a user in the app, the health worker will be notified through this app. The health worker can also track the pregnant women under their care through this application. A cloud-based database of pregnant women will have the details of all the pregnant women in a given ward or rural municipality. Health coordinators in the municipality will be able to access the database for their municipality and track the pregnant women, if needed.

Also known as: Mobile Phone Application

Mobile Phone and Cloud-based Electronic Contact and Recording System

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amit Arjyal: lead
• Bagmati Rural Municipality, Lalitpur, Nepal: collaborator
• Konjyosom Rural Municipality, Lalitpur, Nepal: collaborator
• Mahankal Rural Municipality, Lalitpur, Nepal: collaborator
• School of Health Sciences, Purbanchal University, Nepal: collaborator

Study Sites (1)

Patan Academy of Health Sciences

Lalitpur, Bagmati, Nepal

Location

Related Publications (8)

• Del Barco R, editor. JHPIEGO Monitoring Birth Preparedness and Complication Readiness, Tools and Indicators for Maternal and Newborn Health. Baltimore (USA): JHPIEGO; 2004. Available from: https://pdf.usaid.gov/pdf_docs/Pnada619.pdf

  BACKGROUND

• Main EK, Abreo A, McNulty J, Gilbert W, McNally C, Poeltler D, Lanner-Cusin K, Fenton D, Gipps T, Melsop K, Greene N, Gould JB, Kilpatrick S. Measuring severe maternal morbidity: validation of potential measures. Am J Obstet Gynecol. 2016 May;214(5):643.e1-643.e10. doi: 10.1016/j.ajog.2015.11.004. Epub 2015 Nov 12.

  PMID: 26582168 BACKGROUND

• Callaghan WM, Creanga AA, Kuklina EV. Severe maternal morbidity among delivery and postpartum hospitalizations in the United States. Obstet Gynecol. 2012 Nov;120(5):1029-36. doi: 10.1097/aog.0b013e31826d60c5.

  PMID: 23090519 BACKGROUND

• Nam JY. Comparison of global indicators for severe maternal morbidity among South Korean women who delivered from 2003 to 2018: a population-based retrospective cohort study. Reprod Health. 2022 Aug 13;19(1):177. doi: 10.1186/s12978-022-01482-y.

  PMID: 35964088 BACKGROUND

• Todd S, Bowen J, Ibiebele I, Patterson J, Torvaldsen S, Ford F, Nippita M, Morris J, Randall D. A composite neonatal adverse outcome indicator using population-based data: an update. Int J Popul Data Sci. 2020 Aug 12;5(1):1337. doi: 10.23889/ijpds.v5i1.1337.

  PMID: 33644407 BACKGROUND

• Huda TM, Chowdhury M, El Arifeen S, Dibley MJ. Individual and community level factors associated with health facility delivery: A cross sectional multilevel analysis in Bangladesh. PLoS One. 2019 Feb 13;14(2):e0211113. doi: 10.1371/journal.pone.0211113. eCollection 2019.

  PMID: 30759099 BACKGROUND

• Neupane B, Rijal S, Gc S, Basnet TB. A Multilevel Analysis to Determine the Factors Associated with Institutional Delivery in Nepal: Further Analysis of Nepal Demographic and Health Survey 2016. Health Serv Insights. 2021 Jun 14;14:11786329211024810. doi: 10.1177/11786329211024810. eCollection 2021.

  PMID: 34177270 BACKGROUND

• Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011 Jun 30;11:102. doi: 10.1186/1471-2288-11-102.

  PMID: 21718530 BACKGROUND

Study Officials

• Ranjan P Devbhandari, MBBS,PhD

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Arjyal, MBBS, DPhil

CONTACT

+9779864478329; amitarjyal@pahs.edu.np

Jeevan Thapa, MBBS, MD

CONTACT

+9779852050660; jeevanthapa@pahs.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 26, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)