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      Cluster randomized trial of a mHealth intervention “ImTeCHO” to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial

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          Abstract

          Background

          To facilitate the delivery of proven maternal, neonatal, and child health (MNCH) services, a new cadre of village-based frontline workers, called the Accredited Social Health Activists (ASHAs), was created in 2005 under the aegis of the National Rural Health Mission in India. Evaluations have noted that coverage of selected MNCH services to be delivered by the ASHAs is low. Reasons for low coverage are inadequate supervision and support to ASHAs apart from insufficient skills, poor quality of training, and complexity of tasks to be performed. The proposed study aims to implement and evaluate an innovative intervention based on mobile phone technology (mHealth) to improve the performance of ASHAs through better supervision and support in predominantly tribal and rural communities of Gujarat, India.

          Methods/design

          This is a two-arm, stratified, cluster randomized trial of 36 months in which the units of randomization will be Primary Health Centers (PHCs). There are 11 PHCs in each arm. The intervention is a newly built mobile phone application used in the public health system and evaluated in three ways: (1) mobile phone as a job aid to ASHAs to increase coverage of MNCH services; (2) mobile phone as a job aid to ASHAs and Auxiliary Nurse Midwives (ANMs) to increase coverage of care among complicated cases by facilitating referrals, if indicated and home-based care; (3) web interface as a job aid for medical officers and PHC staff to improve supervision and support to the ASHA program. Participants of the study are pregnant women, mothers, infants, ASHAs, and PHC staff.

          Primary outcome measures are a composite index made of critical, proven MNCH services and the proportion of neonates who were visited by ASHAs at home within the first week of birth. Secondary outcomes include coverage of selected MNCH services and care sought by complicated cases. Outcomes will be measured by conducting household surveys at baseline and post-intervention which will be compared with usual practice in the control area, where the current level of services provided by the government will continue. The primary analysis will be intention to treat.

          Discussion

          This study will help answer some critical questions about the effectiveness and feasibility of implementing an mHealth solution in an area of MNCH services.

          Trial registration

          Clinical Trial Registry of India, CTRI/2015/06/005847. Registered on 3 June 2015.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-017-1998-0) contains supplementary material, which is available to authorized users.

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          Most cited references12

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          Evidence-based, cost-effective interventions: how many newborn babies can we save?

          In this second article of the neonatal survival series, we identify 16 interventions with proven efficacy (implementation under ideal conditions) for neonatal survival and combine them into packages for scaling up in health systems, according to three service delivery modes (outreach, family-community, and facility-based clinical care). All the packages of care are cost effective compared with single interventions. Universal (99%) coverage of these interventions could avert an estimated 41-72% of neonatal deaths worldwide. At 90% coverage, intrapartum and postnatal packages have similar effects on neonatal mortality--two-fold to three-fold greater than that of antenatal care. However, running costs are two-fold higher for intrapartum than for postnatal care. A combination of universal--ie, for all settings--outreach and family-community care at 90% coverage averts 18-37% of neonatal deaths. Most of this benefit is derived from family-community care, and greater effect is seen in settings with very high neonatal mortality. Reductions in neonatal mortality that exceed 50% can be achieved with an integrated, high-coverage programme of universal outreach and family-community care, consisting of 12% and 26%, respectively, of total running costs, plus universal facility-based clinical services, which make up 62% of the total cost. Early success in averting neonatal deaths is possible in settings with high mortality and weak health systems through outreach and family-community care, including health education to improve home-care practices, to create demand for skilled care, and to improve care seeking. Simultaneous expansion of clinical care for babies and mothers is essential to achieve the reduction in neonatal deaths needed to meet the Millennium Development Goal for child survival.
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            How changes in coverage affect equity in maternal and child health interventions in 35 Countdown to 2015 countries: an analysis of national surveys.

            Achievement of global health goals will require assessment of progress not only nationally but also for population subgroups. We aimed to assess how the magnitude of socioeconomic inequalities in health changes in relation to different rates of national progress in coverage of interventions for the health of mothers and children. We assessed coverage in low-income and middle-income countries for which two Demographic Health Surveys or Multiple Indicator Cluster Surveys were available. We calculated changes in overall coverage of skilled birth attendants, measles vaccination, and a composite coverage index, and examined coverage of a newly introduced intervention, use of insecticide-treated bednets by children. We stratified coverage data according to asset-based wealth quintiles, and calculated relative and absolute indices of inequality. We adjusted correlation analyses for time between surveys and baseline coverage levels. We included 35 countries with surveys done an average of 9·1 years apart. Pro-rich inequalities were very prevalent. We noted increased coverage of skilled birth attendants, measles vaccination, and the composite index in most countries from the first to the second survey, while inequalities were reduced. Rapid changes in overall coverage were associated with improved equity. These findings were not due to a capping effect associated with limited scope for improvement in rich households. For use of insecticide-treated bednets, coverage was high for the richest households, but countries making rapid progress did almost as well in reaching the poorest groups. National increases in coverage were primarily driven by how rapidly coverage increased in the poorest quintiles. Equity should be accounted for when planning the scaling up of interventions and assessing national progress. Bill & Melinda Gates Foundation; World Bank; Governments of Australia, Brazil, Canada, Norway, Sweden, and UK. Copyright © 2012 Elsevier Ltd. All rights reserved.
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              Development and formative evaluation of an innovative mHealth intervention for improving coverage of community-based maternal, newborn and child health services in rural areas of India

              Background A new cadre of village-based frontline health workers, called Accredited Social Health Activists (ASHAs), was created in India. However, coverage of selected community-based maternal, newborn and child health (MNCH) services remains low. Objective This article describes the process of development and formative evaluation of a complex mHealth intervention (ImTeCHO) to increase the coverage of proven MNCH services in rural India by improving the performance of ASHAs. Design The Medical Research Council (MRC) framework for developing complex interventions was used. Gaps were identified in the usual care provided by ASHAs, based on a literature search, and SEWA Rural's1 three decades of grassroots experience. The components of the intervention (mHealth strategies) were designed to overcome the gaps in care. The intervention, in the form of the ImTeCHO mobile phone and web application, along with the delivery model, was developed to incorporate these mHealth strategies. The intervention was piloted through 45 ASHAs among 45 villages in Gujarat (population: 45,000) over 7 months in 2013 to assess the acceptability, feasibility, and usefulness of the intervention and to identify barriers to its delivery. Results Inadequate supervision and support to ASHAs were noted as a gap in usual care, resulting in low coverage of selected MNCH services and care received by complicated cases. Therefore, the ImTeCHO application was developed to integrate mHealth strategies in the form of job aid to ASHAs to assist with scheduling, behavior change communication, diagnosis, and patient management, along with supervision and support of ASHAs. During the pilot, the intervention and its delivery were found to be largely acceptable, feasible, and useful. A few changes were made to the intervention and its delivery, including 1) a new helpline for ASHAs, 2) further simplification of processes within the ImTeCHO incentive management system and 3) additional web-based features for enhancing value and supervision of Primary Health Center (PHC) staff. Conclusions The effectiveness of the improved ImTeCHO intervention will be now tested through a cluster randomized trial.
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                Author and article information

                Contributors
                dhirenpsm@gmail.com
                091-2645-220021 , 091-9429109050 , sdesai1977@yahoo.com
                kapil.dave88@gmail.com
                shahshobha30@gmail.com
                shreygayatri@gmail.com
                91-9925185846 , nbdholakia@rediffmail.com
                rgopalan@argusoft.com
                pankaj8892@yahoo.co.in
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                9 June 2017
                9 June 2017
                2017
                : 18
                : 270
                Affiliations
                [1 ]Community Health Department, SEWA-Rural, Jhagadia, District, Bharuch, Gujarat 393110 India
                [2 ]ISNI 0000 0001 0658 0454, GRID grid.464868.0, , Commissionerate of Health, Government of Gujarat, ; Block 5, Dr. Jivraj Mehta Bhavan, Gandhinagar, Gujarat 382010 India
                [3 ]Argusoft India Ltd., GIDC electronic estate, Sector 25, Gandhinagar, 382016 Gujarat India
                Article
                1998
                10.1186/s13063-017-1998-0
                5466719
                28599674
                908620a8-69dd-40c7-9ac7-63578d5c629a
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 July 2016
                : 19 May 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001411, Indian Council of Medical Research;
                Award ID: 5/7/589/Gujarat/2011-RCH
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100004423, World Health Organization;
                Award ID: MCA00615
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000870, John D. and Catherine T. MacArthur Foundation;
                Award ID: G-108398-0
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Medicine
                mhealth,ashas,crct,maternal health,neonatal health,acceptability,tribal health,implementation research,india

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