Open Access Highly Accessed Study protocol

Effectiveness of a smart phone app on improving immunization of children in rural Sichuan Province, China: study protocol for a paired cluster randomized controlled trial

Li Chen1, Wei Wang1, Xiaozhen Du1, Xiuqin Rao1, Michelle Helena van Velthoven2, Ruikan Yang3, Lin Zhang4, Jeanne Catherine Koepsell5, Ye Li1, Qiong Wu1 and Yanfeng Zhang1*

Author Affiliations

1 Department of Integrated Early Childhood Development, Capital Institute of Paediatrics, No. 2 Yabao Road, Chaoyang District, Beijing 100020, P.R. China

2 Global eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom

3 Save the Children China Program, Beijing, China

4 Save the Children China Program, Chengdu, China

5 Save the Children, Washington DC, USA

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BMC Public Health 2014, 14:262  doi:10.1186/1471-2458-14-262

Published: 20 March 2014



Although good progress has been achieved in expanding immunization of children in China, disparities exist across different provinces. Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas. The rapid development of mobile health technology (mHealth) provides unprecedented opportunities for improving health services and reaching underserved populations. However, there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications (apps). This study aims to assess the effectiveness of a smart phone-based app (Expanded Program on Immunization app, or EPI app) on improving the coverage of children’s immunization.


This cluster randomized trial will take place in Xuanhan County, Sichuan Province, China. Functionalities of the app include the following: to make appointments automatically, record and update children’s immunization information, generate a list of children who missed their vaccination appointments, and send health education information to village doctors. After pairing, 36 villages will be randomly allocated to the intervention arm (n = 18) and control arm (n = 18). The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas. A household survey will be used at baseline and at endline (8 months of implementation). The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine, Rotavirus vaccine and Pneumococcal conjugate vaccine. Multidimensional evaluation of the app will also be conducted to assess usability and feasibility.


This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China. This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings.

Trial registration

Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960

Randomized controlled trial; Immunization [MeSH]; Usability; Feasibility Studies [MeSH]