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一项关于移动健康干预措施“ImTeCHO”的整群随机试验:通过印度古吉拉特邦部落地区的社区认证社会健康活动家(ASHAs),增强其积极性并加强监督,以改善已证实的孕产妇、新生儿和儿童保健干预措施的实施:一项随机对照试验的研究方案

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.

作者信息

Modi Dhiren, Desai Shrey, Dave Kapilkumar, Shah Shobha, Desai Gayatri, Dholakia Nishith, Gopalan Ravi, Shah Pankaj

机构信息

Community Health Department, SEWA-Rural, Jhagadia, District, Bharuch, Gujarat, 393110, India.

Commissionerate of Health, Government of Gujarat, Block 5, Dr. Jivraj Mehta Bhavan, Gandhinagar, Gujarat, 382010, India.

出版信息

Trials. 2017 Jun 9;18(1):270. doi: 10.1186/s13063-017-1998-0.

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.

摘要

背景

为促进已证实有效的孕产妇、新生儿和儿童健康(MNCH)服务的提供,2005年在印度国家农村卫生使命的支持下,创建了一个新的村级一线工作者队伍,称为经认证的社会健康活动家(ASHAs)。评估指出,ASHAs应提供的特定MNCH服务的覆盖率较低。覆盖率低的原因除了技能不足、培训质量差和执行任务复杂外,还包括对ASHAs的监督和支持不足。拟议的研究旨在实施和评估一项基于移动电话技术(移动健康)的创新干预措施,通过在印度古吉拉特邦主要是部落和农村社区提供更好的监督和支持,来提高ASHAs的绩效。

方法/设计:这是一项为期36个月的双臂、分层、整群随机试验,随机分组单位将是初级卫生中心(PHCs)。每组有11个初级卫生中心。干预措施是一个新开发的用于公共卫生系统的移动电话应用程序,并通过三种方式进行评估:(1)将移动电话作为ASHAs的工作辅助工具,以提高MNCH服务的覆盖率;(2)将移动电话作为ASHAs和辅助护士助产士(ANMs)的工作辅助工具,通过在必要时促进转诊和提供居家护理,来提高复杂病例的护理覆盖率;(3)将网络界面作为医务人员和初级卫生中心工作人员的工作辅助工具,以改善对ASHAs项目的监督和支持。该研究的参与者包括孕妇、母亲、婴儿、ASHAs和初级卫生中心工作人员。主要结局指标是一个由关键的、已证实有效的MNCH服务组成的综合指数,以及ASHAs在新生儿出生后第一周内进行家访的比例。次要结局包括特定MNCH服务的覆盖率以及复杂病例寻求的护理。结局将通过在基线和干预后进行家庭调查来衡量,并将其与对照地区的常规做法进行比较,对照地区将继续提供政府目前的服务水平。主要分析将采用意向性分析。

讨论

本研究将有助于回答一些关于在MNCH服务领域实施移动健康解决方案的有效性和可行性的关键问题。

试验注册

印度临床试验注册中心,CTRI/2015/06/005847。于2015年6月3日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b4e/5466719/f29768af1349/13063_2017_1998_Fig1_HTML.jpg

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