Condition category
Not Applicable
Date applied
03/11/2016
Date assigned
08/12/2016
Last edited
07/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Community health workers, such as Anganwadi workers (AWWs) in India, are an important workforce in low- and middle-income countries with unmet potential for providing care. Although AWWs have achieved many successes, there is a great potential for AWW effectiveness to be improved through the use of mobile technology. There is very little existing research on the causal effects of Monitoring and Information Systems on maternal, infant or child outcomes in developing countries. Existing research in low- and middle-income countries has mostly focused on the use of technologies to track the attendance and punctuality of health and primary education, but there is not much evidence on how these technologies affect health outcomes. Therefore there is a significant research gap in the understanding of how monitoring and information technologies affect community health worker behavior, efficiency and effectiveness, and how these technologies ultimately affect health outcomes in the community. The Ministry of Women and Child Development in India developed a technology-based intervention to improve service delivery at Anganwadi Centers, ensure better supervision of the Integrated Child Development Services (ICDS) scheme and enable data based decision making. This technology intervention is called the Common Application Software (CAS) and is intended to be a job aid for Anganwadi Workers (AWWs). The goal of the CAS intervention is to strengthen the Integrated Child Development Scheme (ICDS) policy framework, system and capacities, and facilitate community engagement, to improve the health of children less than six years of age; and strengthen convergent actions for improved nutrition outcomes. The aim of this study is to test the overall impact of the CAS intervention on AWW behaviors, knowledge and time use, describe potential pathways for explaining program success and failures, and provide suggestions and solutions for potential scale-up of the program.

Who can participate?
Pregnant women, mothers and children living in participating areas, Anganwadi Workers (AWWs) and their assistants, ICDS officials and other government officials.

What does the study involve?
Participating Anganwadi centers are allocated to either be intervention centres or control centres. In the intervention centres, Anganwadi workers receive an Android-platform phone with an application (CAS) specifically designed to help them register participants and prioritize activities. In the control centres, Anganwadi workers receive no phone and proceed with standard care using a paper-based system. In both groups, the time taken to record key patient information is compared. In addition, the growth and weight of children being treated by Anganwadi workers are measured at the start of the study and one year later.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. Some study participants might experience some stress while answering interview questions. This might be more true with women in rural India, who are generally not allowed to speak with people outside of their immediate family. However this is an extremely low degree of potential harm. Study participants will not have to bare any economic cost, and there will be no physical requirements.

Where is the study run from?
The study is run from International Food Policy Research Institute and takes place in Anganwadi centers in Bihar and Madhya Pradesh (India)

When is the study starting and how long is it expected to run for?
January 2016 to July 2018

Who is funding the study?
Bill and Melinda Gates Foundation (USA)

Who is the main contact?
Miss Carol Hui
carolhui@berkeley.edu

Trial website

Contact information

Type

Scientific

Primary contact

Miss Carol Hui

ORCID ID

Contact details

University of California
Berkeley
School of Public Health
50 University Hall
Berkeley
94720-7360
United States of America
+1 510 666 3734
carolhui@berkeley.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Effects of switching from paper-based to tablet-based record system on health outcomes in women and children: A quasi-experimental study of community health workers in India

Acronym

Study hypothesis

The aim of this study is to:
1. Evaluate the effectiveness of a Common Application Software (CAS) intervention which assists community health workers (known as Anganwadis) perform key functions within the India’s Integrated Child Development Scheme (ICDS) framework
2. Assess the CAS intervention's impact on the outreach and effectiveness of Anganwadi workers (AWW), Anganwadi helpers and AWW supervisors.
3. Assess the impact CAS has on health outcomes in women and children and on their knowledge and practices related to health and nutrition

Ethics approval

Not provided at time of registration

Study design

Multi-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Maternal and child health

Intervention

Anganwadi centers will be selected from treatment areas (which are determined by the Indian government); each Anganwadi center has one Anganwadi worker and is overseen by a supervisor who has 20 Anganwadi centers in her cluster. Comparison centers will be selected from which the control sample will be selected.

Intervention group: Anganwadi workers in treatment groups will receive an Android-platform phone with an application (CAS) specifically designed to help them register participants and prioritize activities.

Control group: Anganwadi workers receive no phone and will proceed with the standard of care, which is a paper-based system.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Time use in minutes spent recording key patient information on CAS app compared to recording the information by hand is measured using photographic and video technology, as well as a survey asking about time use in the past 24 hours at baseline and endline, as well as some qualitative data that will be collected throughout the process.

Secondary outcome measures

1. Child growth is measured using stadiometers and infantometers at baseline and 1 year
2. Child weight is measured using weighing scales at baseline and 1 year

Overall trial start date

09/01/2016

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women
2. Mothers
3. Anganwadi Workers (AWWs)
4. AWW assistants
5. ICDS officials
6. Children
7. Other government officials

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

100

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/01/2017

Recruitment end date

01/08/2017

Locations

Countries of recruitment

India

Trial participating centre

International Food Policy Research Institute
Dev Prakash Shastri Marg Pusa
New Delhi
110012
India

Sponsor information

Organisation

Bill & Melinda Gates Foundation

Sponsor details

500 Fifth Avenue North
Seattle
98109
United States of America

Sponsor type

Charity

Website

www.gatesfoundation.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact, peer-reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes