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CTRI Number  CTRI/2015/06/005847 [Registered on: 03/06/2015] Trial Registered Retrospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Implementation science and health system]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Assess effectiveness of a new mobile phone application towards improving community based maternal, newborn and child health services in tribal areas of Gujarat 
Scientific Title of Study   Use of mHealth Solutions to Improve Delivery of Proven Maternal, and Newborn Care Interventions through Community Based Accredited Social Health Activists (ASHAs) by Enhancing Their Motivation and Strengthening Supervision in Tribal Areas of Gujarat, India: A Cluster Randomized trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Shah 
Designation  Managing trustee and Principal Investigator 
Affiliation  SEWA Rural 
Address  SEWA Rural Jhagadia District Bharuch Gujarat PIN 393110

Bharuch
GUJARAT
393110
India 
Phone  9426120316  
Fax  02645220313  
Email  pankaj8892@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Shah 
Designation  Managing trustee and Principal Investigator 
Affiliation  SEWA Rural 
Address  SEWA Rural Jhagadia District Bharuch Gujarat PIN 393110

Bharuch
GUJARAT
393110
India 
Phone  9426120316  
Fax  02645220313  
Email  pankaj8892@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Shah 
Designation  Managing trustee and Principal Investigator 
Affiliation  SEWA Rural 
Address  SEWA Rural Jhagadia District Bharuch Gujarat PIN 393110

Bharuch
GUJARAT
393110
India 
Phone  9426120316  
Fax  02645220313  
Email  pankaj8892@yahoo.co.in  
 
Source of Monetary or Material Support
Modification(s)  
Department of maternal, newborn, child and adolescent health, World Health Organization  
Financial support: Indian Council of Medical Research,P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India. Technical partner: ICMR and WHO, P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India. Implementation partner: The Department of Health and Family Welfare, Government of Gujarat, Block 5, Dr Jivraj Mehta Bhavan, Gandhinagar, Gujarat, India 382010.  
John D and Catherine T MacArthur Foundation 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Department of maternal newborn child and adolescent health World Health Organization  World Health Organization Avenue Appia 20 1211 Geneva 27 Switzerland 
John D and Catherine T MacArthur Foundation  India Habitat Centre Zone VA, First Floor Lodhi Road New Delhi 110 003 India  
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Shah  SEWA Rural  Community Health Department Jhagadia District Bharuch
Bharuch
GUJARAT 
9426120316
02645220313
pankaj8892@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Multi-institutional ethics committee   Approved 
SEWA Rural Institutional Ethics Committee  Approved 
WHO Research Ethics Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Maternal, newborn and child mortality, malnutrition and other complications 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  The control area will continue to receive usual health services from government and other providers. All ASHAs in control and intervention area will be trained to get up-to-date to provide recommended maternal, newborn and child care. ASHAs will receive refreshers’ training based on ASHA module-6 and 7 which provides skills for the maternal care services that she is expected to deliver including counselling pregnant women, ensuring complete antenatal care through home visits and enabling care at monthly Village Health and Nutrition Days (VHND), assisting households to make birth plan and supporting households for safe delivery. Regarding newborn care, ASHAs will be trained to undertake at least 6 post-partum visits, counsel and problem solve on breastfeeding, keep the baby warm and identify and do basic management of LBW (Low Birth Weight) and pre-term baby, perform examinations needed for identification/first contract care for sepsis and asphyxia. 
Intervention  ImTeCHO (Innovative Mobile-phone Technology for Community Health Operations) mobile and web application  Intervention (called “ImTeCHO”) is a platform based on mobile phone technology to improve coverage of proven community based maternal, newborn and child health (MNCH) services through improving performance of ASHAs and PHC staff by providing support, supervision and motivation. The intervention has four components: 1. Use of ImTeCHO mobile and web based application by ASHAs, medical officers and PHC staff Every ASHA will be given a low cost phone which will be General Packet Radio Service (GPRS) enabled. ASHA will fill out forms on her mobile during home visits. Data will be sent using GPRS network to a server where data will be stored. 1.1 Mobile phone as job aid to ASHA to increase coverage MNCH care - Schedule reminder to ASHAs to make home visit - Home visit forms having checklist to remind scheduled tasks - Multimedia to improve counseling - Checklists to assess and address barriers to behavior change of families (e.g. birth preparedness, complication readiness) - Checklist to remind tasks to be performed during VHND 1.2 Mobile phone as job aid to ASHA and ANM to facilitate care for mother, newborn and child with complications - Diagnostic tool: Checklist and In-built algorithms to identify mother or newborn with complications and automatic risk stratification - Tool to facilitate referral to functional referral facility (for calling 108/emergency transport etc) - Notification alert for ANM once complicated case is identified by ASHA - Manage morbidity by displaying customized management guidelines to help ASHA manage complicated cases at home who refuse get referred to health facility 1.3 Web interface and mobile phone to provide tools to medical officer and PHC staff to facilitate monitoring and supporting program - Daily follow-up of selected high risk cases - Performance monitoring - Monthly reports - Supply management - Calculation and timely payment of incentive to ASHAs - Announcements - Motivating ASHAs as the system will display a message about incentive earned after delivery of a service 2. Helpline to provide care for complicated cases over telephone. 3. mHealth facilitators from SEWA Rural will be first contact for ASHAs and PHC staff to report and solve any problem with the ImTeCHO application and other related issues. The mHealth facilitators will monitor adherence to the intervention through use of set of process indicators. 4. Training of ASHAs and PHC staff for use of application and refresher training 5. Head quarter project team at SEWA Rural and district health societies which will supervise and support the project team along with coordinate with the government health staff. Ongoing software updates will be done based on ongoing feedback and report of bugs or errors. The project team might intervene in case of rare emergency situation.  
 
Inclusion Criteria
Modification(s)  
Age From  31.00 Day(s)
Age To  9.00 Month(s)
Gender  Both 
Details  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:
• 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.
• 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.  
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Primary outcome 1
Proportion of neonates/mothers who received at least two postnatal home visits within first week of delivery by ASHA
Primary outcome 2
Modified ASHA-centric Composite Coverage Index
 
At baseline (May to July, 2015) and endline (February, to July 2017) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
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 received satisfactory ANC counseling (at least 5 of below)

a. Birth planning and complication readiness,
b. Conveyed expected date of delivery,
c. Danger signs of pregnancy,
d. examination by ANM/doctor,
e. Institutional delivery,
f. Early essential newborn care,
g. Contacting ASHA if danger sign appears
 
At endline  
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 neonates/mothers who received at least two postnatal home visits within first week of delivery by ASHA   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
b. Proper attachment for breast feeding
c. Keeping baby warm by covering in cloth
d. Delaying first bath
e. Kangaroo mother care
f. Caring for umbilical cord
g. Washing hands before handling baby
h. Vaccination
i. Danger signs of newborn
 
At endline 
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
b. Took weight of newborn
c. Examined skin and umbilicus
d. Washed her hands before examining
e. Observed breast feeding the baby in her presence
 
At endline 
Proportion of mothers who were counselled by ASHA for young child within last three months

a. Initiate complementary food at six months
b. Adding oil, sugar and jiggery to food
c. Informed status of child on WHO growth chart (green, yellow or red) within last 3 months
 
At endline 
Proportion of mothers who were counselled for seeking care for young child within last 3 months

a. To attend VHND
b. To contact ASHA in case the child suffers from diarrhea, fever or pneumonia
 
At endline 
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 mothers who were able to state at least three danger signs of pregnancy  At 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
b.Colostrums was fed
c. Bathing delayed after first day
d. No prelacteal feed administered
 
At endline 
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
Did not apply anything on cord
Washed hands before handling baby
 
At endline 
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
-ASHA Task completion rate
-Number of pregnancy registration forms filled using mobile phones against expected number of registration
-Proportion of live and still births reported on the day of outcome
-VHND attendance rate
-Number of complicated maternal (severe anaemia), newborn (LBW) and child (severe underweight) cases identified against expected
-Medical officer login and task completion rate
-Stock out rate

 
Ongoing during the study period 
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 Rural’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 Rural’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 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  
26/08/2015 
Date of Study Completion (India) 31/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   A peer reviewed article regarding development and formative evaluation of the ImTeCHO intervention can be found at http://www.ncbi.nlm.nih.gov/pubmed/25697233.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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 ASHA’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 ASHAs’ 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 “Innovative Mobile-phone Technology for Community Health Operations”. “Techo” in Gujarati means “support”; hence, ImTeCHO means “I am support”. 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 government’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.


 
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