Assess effectiveness of a new mobile phone application towards improving community based maternal, newborn and child health services in tribal areas of Gujarat

Phase 3

Completed

Conditions: Maternal, newborn and child mortality, malnutrition and other complications

Registration Number: CTRI/2015/06/005847

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Proposed study aims to implement, and evaluate an innovative intervention based on mobile phone technology to help ASHAs improve coverage of maternal, newborn and child health (MNCH) services in predominantly tribal and rural communities. The intervention will also include tools for medical officers and PHC staff to better monitor and support ASHAs.

Over the course of last decade, significant evidence has been generated about effectiveness of community based interventions which can reduce maternal, newborn and child mortality and morbidity. To facilitate implementation of the proven interventions, a new cadre of village based Community Health Workers, called Accredited Social Health Activist (ASHA), was created under the aegis of the National Rural Health Mission (NHRM). Many of the community based maternal, newborn and child interventions are expected to be implemented or facilitated by ASHA during her scheduled home visits. Unfortunately, evaluations examining ASHAâ€™s performance have noted that coverage of selected MNCH interventions to be implemented by ASHA is low. One of the most important reasons for low coverage is inadequate information to monitor and support ASHAsâ€™ activities apart from insufficient skills of ASHAs, quality of training, and complexity of tasks to be performed. Also, large numbers of complicated maternal, newborn and child cases are unable to go to a health facility. The non-availability of real time information about such cases to Auxiliary Nurse Midwife (ANMs) and medical officers has limited their ability to respond; hence, such complicated cases at home tend not to receive any care.

Proposed intervention is an innovative strategy to overcome above problems by using mobile phone technology (called mHealth solutions) to empower ASHAs and PHC staff. The mHealth intervention is named *ImTeCHO* which stands for â€œInnovative Mobile-phone Technology for Community Health Operationsâ€. â€œTechoâ€ in Gujarati means â€œsupportâ€; hence, *ImTeCHO* means â€œI am supportâ€. mHealth intervention, *ImTeCHO* will be used in 3 ways: (1) Mobile phone as a job aid to ASHAs to increase coverage of MNCH care (2) Mobile phone as a job aid to ASHAs and ANMs to facilitate referral and care for mothers, newborns and children with complications (3) Web interface to provide timely information to medical officers for monitoring and supporting program, including accurate and timely reporting of births and deaths. Proposed *ImTeCHO* intervention will integrate checklist (to insure standardization of services) with other features that mobile technology offers such as ability to transfer data instantly and apply algorithm automatically to data entered along with features to ensure check-and-balance for truthfulness and accuracy of collected information. All this will be possible by using a low-cost phone costing approximately Rs.5,000 (US $ 80). Rather then creating a new model, ImTeCHO intervention will use mHealth solutions to improve implementation of existing responsibilities of ASHAs. *ImTeCHO* intervention will be implemented within governmentâ€™s existing primary health care system which will be actively facilitated by SEWA Rural. The duration of study will be 36 months.

The study will test the effectiveness of intervention to improve: (1) Coverage of maternal, newborn and child health-care services to be provided by ASHA, (2) Coverage of care received by complicated maternal, newborn and child cases and (3) Supervision and support to ASHA program. This will be a two-arm cluster randomized trial which will be conducted in six high focus, tribal blocks (Population: 450,000) of Bharuch and Narmada districts in Gujarat with 11 Primary Health Centers in each arm. Approximately 33,000 pregnant women, newborn babies and young children will be directly benefitted. Primary outcome of interests will be measured by conducting household surveys at baseline, and post-intervention.

Results of this study will have significant implications on policy. At the end of the study, exact road map for implementation of ImTeCHO in larger system will be ready as following deliverables will be produced: training modules for using mobile phones, implementation plan for introducing mHealth solutions for MNCH care in larger system, a comprehensive report and creation of a demonstration site. Proposed intervention including mobile phone application and web interface can complement existing online Mother and Child Tracking System (MCTS) in use and further enhance inherent usefulness of Mother and Child Tracking System (MCTS). Apart from facilitating provision of services, the intervention will provide timely, reliable and accurate information for birth and death reporting. Lessons learned from this study will be helpful to guide use of mobile phone technology in other disease areas.

This study will be conducted by Society for Education, Welfare and Awareness (SEWA) Rural, Jhagadia. SEWA Rural and Argusoft India Ltd have developed ImTeCHO intervention. The Department of Health & Family Welfare, Government of Gujarat and SEWA Rural will implement the intervention. SEWA Rural will evaluate the intervention with help of experts from ICMR and WHO.

The trial was registered on 3 June, 2015. The first enrollment was done on 26 August, 2015. Therefore, this is a prospectively registered trial. However, the message on the CTRI website states that the trial was registered retrospectively. This has happened because of a human error in stating the date of first enrollment when the trial was registered by the investigators. However, the date of first enrollment is now corrected on the CTRI website and this is in fact a prospectively registered trial.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 22

Inclusion Criteria

As this is a cluster randomized trial, there are two categories for inclusion and exclusion criteria.
For selecting clusters: All clusters (PHCs) belonging to Valia, Netrang (except those where ImTeCHO is being implemented already as part of another project), Dediyapada, Nandod, Garudeshwar and Tilakwada blocks in Gujarat with 100% rural population and scheduled tribe population of more than 45% will be eligible to be included.
For enrolling respondents for endline survey: â€¢For coverage of maternal, and newborn health services: All woman who are native of study village and is mother of an infant who is one to four months old at the time of survey will be considered as respondents for evaluation.
All native women who resided most of the time (at least five months) in study cluster during antenatal period will be included.
All women must be in the study cluster at the time of birth in case of home deliveries and in case of institutional deliveries if the she went to hospital from study cluster and came back to same study cluster immediately after delivery, and who provided consent for the evaluation will be included.
All women who resided in study cluster for most of time during first month after delivery will be included.
â€¢For coverage of child health services: All woman who are native of study cluster and is mother of an infant who is six to eight months old at the time of survey will be considered as respondents for evaluation.

Exclusion Criteria

For selecting clusters:Those PHCs will be excluded where all medical officer posts, and 20% post for ASHAs are vacant at the time of initiation of study.
Those PHCs will be excluded whose more than 10% villages have no mobile signal most of the time.
Although ImTeCHO mobile application can function without GPRS signal, lack of such signal in large areas of intervention will affect components of intervention to significant extent.
PHCs where internet cannot be accessed reliably by medical officer and PHC staff to view web interface and an alternative arrangement is not possible will be excluded too as web interface is important part of the ImTeCHO intervention.
For enrolling respondents for endline survey, following respondents will be excluded: 1.
Mothers who had twins/multiple births 2.
Infants who died before survey 3.
Not willing to provide consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome 1	At baseline (May to July, 2015) and endline (February, to July 2017)
Proportion of neonates/mothers who received at least two postnatal home visits within first week of delivery by ASHA	At baseline (May to July, 2015) and endline (February, to July 2017)
Primary outcome 2	At baseline (May to July, 2015) and endline (February, to July 2017)
Modified ASHA-centric Composite Coverage Index	At baseline (May to July, 2015) and endline (February, to July 2017)

Secondary Outcome Measures

Name	Time	Method
Proportion of mothers who were visited at home by ASHA at least three times during last pregnancy including at least one visit during last trimester	At baseline and endline
Proportion of mothers who were counselled for seeking care for young child within last 3 months	a. To attend VHND
Proportion of mothers who had first antenatal examination within first trimester	At baseline and endline
Proportion of mothers who had 4 or more ANC examination by ANM/doctor including at least one examination in last trimester	At baseline and endline
Proportion of mothers who had full antenatal checkup (at least three antenatal examination, one Inj.TT and 100 IFA tablets)	At baseline and endline
Proportion of neonates/mothers who received the recommended number of postnatal home visits and at recommended times within first month of delivery by ASHA. Recommended postnatal visits are defined as at least five home visits within first month of delivery including at least two home visits within first week of delivery	At baseline and endline
Proportion of mothers who received satisfactory education/counseling (at least five of following) about caring for newborn baby from ASHA during her home visits after last delivery	a. Exclusive breast feeding
Proportion of neonates who were satisfactorily examined (at least three of following) by ASHA during her home visits after last delivery	a. Took temperature of newborn
Proportion of mothers who were counselled by ASHA for young child within last three months	a. Initiate complementary food at six months
Proportion of mothers who were able to state at least three danger signs of pregnancy	At endline
Proportion of neonates/mothers who received at least two postnatal home visits within first week of delivery by ASHA	At baseline and endline
Proportion of mothers who received satisfactory ANC counseling (at least 5 of below)
Proportion of neonates/mothers who were visited by ASHA at home within 24 hours of delivery (in case of home delivery) or within 24 hours of return to home from hospital in case of hospital delivery	At baseline and endline
Proportion of mothers who received at least one dose of Inj.TT during last pregnancy	At baseline and endline
Proportion of mothers who consumed at least 100 Iron-Folic Acid (IFA) tablets during last pregnancy	At baseline and endline
Proportion of mothers who delivered at a facility	At baseline and endline
Proportion of mothers who practiced following newborn care immediately after delivery	a. Early initiation (within 1 hour) of breastfeeding
Proportion of mothers who were able to state at least three danger signs of newborn	At endline
Proportion of mother/family who practiced following at home during first month after delivery	Kangaroo mother care for low birth weight baby
Proportion of mothers who practiced exclusive breast feeding until just under 6 months of age	At baseline and endline
Proportion of children who were weighted at least once during last 3 months	At baseline
Proportion of children who received solid, semi-solid or soft foods during previous day	At baseline and endline
Proportion of children who were fed solid, semisolid or soft food at least twice within last 24 hours (Minimum meal frequency)	At endline
Proportion of children who were fed solid, semisolid or soft food with added oil, jiggery or sugar at least once during previous day	At endline
Proportion of mother who knew status of child on WHO growth chart	At endline
Proportion of children who visited ANM or doctor at least once within last 3 months (at VHND or any health facility)	At endline
Proportion of mothers who knew that she can contact ASHA for help in case child suffers from diarrhea, fever or pneumonia	At endline
Proportion of children who received all three doses of pentavalent/DPT3 vaccines	At baseline and endline
Proportion of mothers who sought help from ASHA for antenatal complication	At endline
Proportion of mothers who sought help from ASHA for postnatal complication	At endline
Proportion of mothers who suffered from at least one serious complications during last pregnancy or within six weeks of last delivery and sought care from a qualified health personnel	At endline
Proportion of neonate who suffered from at least one complication within one month of last delivery and sought help from ASHA	At baseline and endline
Proportion of neonate who suffered from at least one complication within one month of last delivery and sought help from qualified health provider	At endline
Proportion of mothers who provided Kangaroo Mother Care (KMC) to their low birth weight babies within first month of last delivery	At endline
Proportion of respondents who were harmed by any medicine given by ASHA	At Endline
Proportion of children who suffered from diarrhea within last two weeks and received ORS from ASHA	At baseline and endline
Proportion of children who suffered from diarrhea within last two weeks and received ORS	At baseline and endline
Proportion of children who suffered from diarrhea within last two weeks and received ORS and continued breast feeding	At endline
Proporetion of children who suffered from ARI/fever within last two weeks and sought care from ASHA	At baseline and endline
Process indicators for intervention area only	-ASHA login rate
Proportion of ASHAs whose performance was reviewed monthly	At endline
Proportion of ASHAs who were contacted by supervisor for non-adherence to intervention	At endline
Proportion of ASHAs who were visited in field by supervisor monthly	At endline
Proportion of PHC meetings when [data from] ImTeCHO was used at least once for supervision by PHC staff	Ongoing during study period
Average number of phone call by SEWA Ruralâ€™s ImTeCHO facilitator per ASHA per month towards providing support	At endline
Proportion of beneficiaries with high risk complications who received guidance from the helpline	Ongoing during study period
Average number of phone call by SEWA Ruralâ€™s helpline per ASHA per month towards providing guidance for morbidity management	At endline
Average number of motivational announcements sent by SEWA Rural to ASHAs per month	At endline
Average amount of extra incentives paid by ImTeCHO project per ASHA per month	Ongoing during study period

Trial Locations

Locations (1): SEWA Rural
🇮🇳
Bharuch, GUJARAT, India
SEWA Rural
🇮🇳Bharuch, GUJARAT, India
Dr Pankaj Shah
Principal investigator
9426120316
pankaj8892@yahoo.co.in