Condition category
Not Applicable
Date applied
03/11/2016
Date assigned
08/12/2016
Last edited
02/08/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 31/07/2018:
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) system and capacities, improve work profile and efficiency of Anganwadi workers, and improve timeliness and appropriateness of ICDS services to the beneficiaries in the short term. Eventually, such improvements in ICDS can lead to term better health and nutrition outcomes for children and mothers. The aim of this study is to test the overall impact of the CAS intervention on AWW knowledge and service delivery to pregnant women, lactating mothers and children <12 months, describe and assess technology and process of the programme to understand potential factors that are associated with program’s success and failures, and provide suggestionsfor potential scale-up of the program

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

What does the study involve?
Participating Anganwadi centers are chosen from the intervention and control districts. In the intervention consists of CAS as job aid, monitoring and data driven decision making tool as described previously. The control group of Anganwadi centers do not receive the intervention but continue to receive standard training, capacity building and infrastructure improvement support under a broader government programme aimed at strengthening the ICDS called ICDS Systems Strengthening & Nutrition Improvement Program. The primary outcomes are related to service delivery by the AWW to pregnant women and mothers of children <12m in terms of adequate number of home visits and appropriate messaging and counselling to beneficiaries by the AWW because ICDS-CAS App is expected to improve these with minimal dependence on any external facilitating factors. The secondary outcomes are several and relate to ICDS functioning, and motivation, knowledge and practices of the AWW in the upstream to the primary outcomes, and improvements in the other ICDS services such as growth monitoring and supplementary nutrition which are dependent on external factors such as timely and sufficient supplies. At the beneficiary levels the secondary outcomes relate to knowledge and practices of the beneficiaries served by the AWWs. Aspirational outcomes which are measured but are not anticipated to change in the study time period are related to health and nutrition of mother and child. These outcomes are measured before and after the intervention is complete and compared between the intervention and control groups to assess if there is any improvement because of the ICDS-CAS intervention in ICDS service delivery.

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 which can collect personal information, check health records and involves height and weight measurement of children.. However, potential for any harm is negligible because the questions are standard and common in many India based surveys, and the participants will have a right to refuse answer to any or all questions. Study participants will not have to bear any financial cost, and there will be no physical requirements.

Where is the study run from?
The study is run from University of California, San Francisco, NEERMAN, and the International Food Policy Research Institute and takes place in approximately 850 Anganwadi centers in the states of Bihar and Madhya Pradesh (India)

When is the study starting and how long is it expected to run for?
January 2016 to July 2019

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

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

Previous plain English summary as of 06/07/2018:
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 knowledge and service delivery to pregnant women and lactating mothers and children <12 months, and to describe and assess technology and process of the programme to understand potential factors that are associated with explaining program’s 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), supervisors of AWWs, ICDS officials and other government officials.

What does the study involve?
Participating Anganwadi centres are chosen from the intervention and control districts. The intervention consists of CAS as job aid, monitoring and data driven decision making tool as described previously. The control group of Anganwadi centers do not receive the intervention but continue to receive standard training, capacity building and infrastructure improvement support under a boarder government programme aimed at strengthening the ICDS. The primary outcomes are related to service delivery by the AWW to pregnant women and mothers of children <12 months in terms of adequate number of home visits, appropriate messaging and counselling to beneficiaries, and growth monitoring of children <12 months. The secondary outcomes related to knowledge and practices of the AWW, and knowledge and practices of the beneficiaries served by the AWWs. Aspirational outcomes which are measured but are not anticipated to change in the study time period are related to health and nutrition of mother and child. These outcomes are measured before and after the intervention is complete and compared between the intervention and control groups to assess if there is any improvement because of the ICDS-CAS intervention in ICDS service delivery.

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 which can collect personal information, check health records and involves height and weight measurement of children. However, the potential for any harm is negligible because the questions are standard and common in many India based surveys, and the participants will have a right to refuse answer to any or all questions. Study participants will not have to bear any economic cost, and there will be no physical requirements.

Where is the study run from?
850 Anganwadi centers in the states of Bihar and Madhya Pradesh (India)

When is the study starting and how long is it expected to run for?
January 2016 to July 2019

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

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


Previous 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 bear 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 a mobile technology based mHealth intervention on service delivery under the Integrated Child Development Scheme of India: a quasi-experimental mixed methods evaluation

Acronym

Study hypothesis

Current study hypothesis as of 06/07/2018:
The aim of this study is to:
1. Evaluate the effectiveness of the ICDS-CAS intervention which assists community health workers (known as Anganwadis) perform key functions within the India’s Integrated Child Development Scheme (ICDS) framework on service delivery to pregnant women, mothers and children <12 m.
2. Assess the pathways of impact (process) and CAS technology with a aim to understand potential for successes and failure when implemented at-scale

Previous 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

Current ethics approval as of 31/07/2018:
University of California, Berkeley, Ref. No. 2016-08-9092, India-based Suraksha Independent Ethics Committee, Protocol No. 2016-08-9092 - 29/03/2017

Previous 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

Current interventions as of 06/07/2018:
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 approx. 20 Anganwadi centers in her cluster. Comparison centers will be selected from the control area where ICDS-CAS is not being implemented currently but will be implemented in future.

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. The supervisors and higher ICDS officials will either get a smart phone or web-based tool to monitor AWW performance. Other support such as training, help-desk, etc will be provided. Intervention group will also continue to receive the standard infrastructure improvement and capacity building support provided to the control group.

Control group: Under a standard ICDS strengthening and improvement programme, the control group will receive upgrades to the ICDS infrastructure and training of the AWW and their supervisors as per the incremental learning approaches.


Previous interventions:
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 measure

Current primary outcome measure as of 31/07/2018:
To assess the effectiveness of ICDS-CAS compared to the standard ISSNIP and ICDS, the following were assessed:
1. The proportion of pregnant women and mothers of children <12 months who received adequate number of home visits by the AWW in 3 months
2.The proportion of pregnant women and mothers of children <12 months who received appropriate extent or level of counselling from the AWW during their interactions (at home, at AWCs, or in other settings) in 3 months

Previous primary outcome measure as of 06/07/2018:
The proportion of ICDS beneficiaries (pregnant & lactating women with children <12 months) who receive appropriate number of home visits and appropriate counselling messages from the Anganwadi workers as per ICDS guidelines; and the proportion of children who receive adequate level of growth monitoring services (weighing, and counselling on nutritional status) from the Anganwadi workers.

Previous primary outcome measure:
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

Current secondary outcome measures as of 06/07/2018:
1. Knowledge of AWWs on topics including birth preparedness, breastfeeding, complementary feeding, and family planning
2. Knowledge of mothers on topics including birth preparedness, breastfeeding, complementary feeding and family planning
3. Practices of mothers around birth preparedness, antenatal care, delivery care, infant and young child feeding practices, family planning, and immunization


Previous 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

01/09/2016

Overall trial end date

01/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current participant inclusion criteria as of 31/07/2018:
1. Pregnant women
2. Mothers of children
3. Children < 60 months of age
4. Anganwadi workers (AWWs)
5. Lady supervisors of the AAws
6. Other ICDS officials
7. Other government officials and private stakeholders

Previous participant inclusion criteria as of 06/07/2018:
1. Pregnant women
2. Mothers of children <24 months of age
3. Children <60 months of age
4. Anganwadi workers (AWWs)
5. Lady supervisors of the AAws
6. Other ICDS officials
7. Other government officials and private stakeholders

Previous 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

More than 800 villages with approx. 6000 women and children, 800 AWWs, 100+ lady supervisors, 20+ ICDS officials, 10+ government and other private stakeholders

Participant exclusion criteria

Current participant exclusion criteria as of 06/07/2018:
1. Non-beneficiaries of the Anganwadi center
2. Not registered to receive ICDS service
Other exclusions criteria may exist as per sampling plan such as excluding villages which are too small or urban areas.
Some beneficiaries of ICDS service may also be excluded - adolescent girls and children under 72 months.

Previous participant exclusion criteria:
No exclusion criteria

Recruitment start date

01/01/2017

Recruitment end date

08/01/2019

Locations

Countries of recruitment

India

Trial participating centre

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

Trial participating centre

UCSF
550 16th Street
San Francisco
94158
United States of America

Trial participating centre

UC Berkeley
2199 Addison Street
Berkeley
94720
United States of America

Trial participating centre

NEERMAN
Mahendra Industrial Coop. Soc. Road No. 29. Sion (East)
Mumbai
400022
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

Current publication and dissemination plan as of 06/07/2018:
Planned publication in a peer-reviewed journal.

Previous 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

01/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/07/2018: The following changes have been made to the trial record: 1. The plain English summary has been changed 2. The ethics approval has been changed 3. The primary outcome measures have been changed 4. The participant inclusion criteria have been changed 5. The trial participating centre addresses have been updated 06/07/2018: The following changes have been made to the trial record: 1. The scientific title has been changed from "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" to "Effects of a mobile technology based mHealth intervention on service delivery under the Integrated Child Development Scheme of India: a quasi-experimental mixed methods evaluation" 2. The study hypothesis has been changed 3. The plain English summary has been changed 4. The primary outcome measures have been changed. 5. The secondary outcome measures have been changed. 6. The overall trial start date has been changed from 09/01/2016 to 01/09/2016. 7. The overall trial end date has been changed from 01/07/2021 to 01/07/2019. 8. The participant inclusion criteria have been changed. 9. Participant inclusion criteria: Target number of participants has been changed from "100" to "More than 800 villages with approx. 6000 women and children, 800 AWWs, 100+ lady supervisors, 20+ ICDS officials, 10+ government and other private stakeholders" 10. The total target enrolment has been changed from "100" to "6930" 11. The participant exclusion criteria have been changed 12. The recruitment end date has been changed from 01/08/2020 to 08/01/2019 13. UCSF, UC Berkeley and NEERMAN have been added as trial participating centres. 14. The publication and dissemination plan has been changed. 22/03/2018: The intention to publish date has been changed from 01/07/2019 to 01/07/2021. 21/03/2018: The following changes have been made: 1. The recruitment end date has been changed from 01/08/2017 to 01/08/2020. 2. The trial end date has been changed from 01/07/2018 to 01/07/2021.