NCT05639595

Brief Summary

The Innovative Mobile Technology for Maternal and Child Health Care (i-MoMCARE) project is a digital health intervention aiming to increase the coverage of and access to maternal and child health (MCH) services for pregnant women and their babies in rural communities in Cambodia. We will fully adopt an innovative model (ImTeCHO) developed, successfully implemented, and evaluated by Society for Education, Welfare and Action-Rural (SEWA Rural) in Gujarat, India. This study will take advantage of Cambodia's well-structured healthcare system, increased internet coverage, and the sharp rise in smartphone adoption to implement innovative mobile technology intervention. i-MoMCARE will provide village health support groups (VHSGs) access and training in mobile-based job aid (mobile apps) to facilitate their work with pregnant women and mothers in the villages. Using mobile apps, VHSGs can register pregnant women and mothers, (re)schedule health care appointments, develop a digital record of the medical history of pregnant women and mothers, show educational videos to pregnant women and mothers, and alert health center staff on high-risk cases. i-MoMCARE will also offer health center staff access to the web interface where they can do longitudinal tracking of VHSGs' log-in rate, track the medical history of patients, and screen for complications and referrals. In Cambodia, long distances to health facilities and inadequate education for women of reproductive age are among the determinants of poor health outcomes, predominantly in rural communities, where the demand for MCH services is high. VHSGs could help overcome the long distance to health facilities with mobile technology. i-MoMCARE could also improve women's understanding of the importance of regular antenatal and postnatal utilization and vaccination and, by extension, reduce high-risk cases and maternal and child deaths. This study is the first to be implemented in Cambodia, contributing to the use of digital health in MCH interventions, which remain in their infancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

November 26, 2022

Last Update Submit

November 10, 2023

Conditions

Keywords

Maternal and child healthPrimary healthcareCommunity health workersAccess to servicesLow- and middle-income countries

Outcome Measures

Primary Outcomes (2)

  • The proportion of neonates/mothers visited at home by village health volunteers

    The proportion of neonates/mothers visited at home by VHSGs at least twice within the first week of delivery

    In the past 12 months

  • The proportion of neonates/mothers receiving information from village health volunteers regarding danger signs of newborn illnesses

    2\. The proportion of neonates/mothers receiving information from VHSGs regarding danger signs of newborn illnesses within the first week of delivery

    In the past 12 months

Secondary Outcomes (8)

  • Mothers completing at least 4 antenatal care

    In the past 12 months

  • Mothers receiving recommended services

    In the past 12 months

  • Mothers visited by village health volunteers

    In the past 12 months

  • Deliveries by skilled provider and in a health facility

    In the past 12 months

  • Mothers with complications seeking care

    In the past 12 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The designated health center staff will receive a web interface that will allow them to offer job aid for supervision, including real-time information about VHSGs' performance in the form of process indicators and coverage of MCH services. The tool will also support health center staff in their daily tasks, such as high-risk patient tracking, low-supply-inventory alerts, supply chain management, electronic health records, vital events tracking, and automatic calculation of performance-based incentives and motivation for VHSGs. The mobile application will be offered to two female VHSGs from each of the 200 villages connected to their respective health centers in the intervention arm. The mobile application will provide job aid to VHSGs for scheduling home visit tasks, including ANC, home-based newborn care, reporting outcomes of pregnancies, and follow-up visits of complicated cases.

Device: Web interface for health center staff and mobile application on smart phones for village health volunteers

Control

NO INTERVENTION

All villages under the health center's catchment areas in the control arm will continue to receive the MCH standard care provided by the government and other local and international non-governmental organizations (NGOs) and facilitated by VHSGs. VHSGs in both intervention and control arms will receive refresher training on maternal, neonatal, and childcare to avoid ethical issues that may arise and to ensure that change in outcomes in the intervention arm is due only to i-MoMCARE, but not the VHSGs MCH training.

Interventions

The designated health center staff will receive a web interface that will allow them to offer job aid for supervision, including real-time information about VHSGs' performance in the form of process indicators and coverage of MCH services. The tool will also support health center staff in their daily tasks, such as high-risk patient tracking, low-supply-inventory alerts, supply chain management, electronic health records, vital events tracking, and automatic calculation of performance-based incentives and motivation for VHSGs. The mobile application will be offered to two female VHSGs from each of the 200 villages connected to their respective health centers in the intervention arm. The mobile application will provide job aid to VHSGs for scheduling home visit tasks, including ANC, home-based newborn care, reporting outcomes of pregnancies, and follow-up visits of complicated cases.

Intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers of children aged 6-24 months
  • Pregnant women aged 18-49

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Battambang Provincial Health Department

Battambang, Cambodia

RECRUITING

Related Publications (1)

  • Saing CH, Ung M, Suy S, Oy S, Dary C, Yam ELY, Chhorn S, Nagashima-Hayashi M, Khuon D, Mam S, Kim R, Saphonn V, Yi S. i-MoMCARE: Innovative Mobile Technology for Maternal and Child Health Care in Cambodia-study protocol of a cluster randomized controlled trial. Trials. 2023 Oct 26;24(1):692. doi: 10.1186/s13063-023-07724-z.

Study Officials

  • Siyan Yi, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siyan Yi, PhD

CONTACT

Mengieng Ung, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 26, 2022

First Posted

December 6, 2022

Study Start

June 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

All data from this study will be available from the principal investigator upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations