title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960.
authors.forename: Li
authors.initials: L
authors.lastname: Chen
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Xiaozhen
authors.initials: X
authors.lastname: Du
authors.forename: Xiuqin
authors.initials: X
authors.lastname: Rao
authors.forename: Michelle Helena
authors.initials: MH
authors.lastname: van Velthoven
authors.forename: Ruikan
authors.initials: R
authors.lastname: Yang
authors.forename: Lin
authors.initials: L
authors.lastname: Zhang
authors.forename: Jeanne Catherine
authors.initials: JC
authors.lastname: Koepsell
authors.forename: Ye
authors.initials: Y
authors.lastname: Li
authors.forename: Qiong
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Integrated Early Childhood Development, Capital Institute of Paediatrics, No, 2 Yabao Road, Chaoyang District, Beijing 100020, P,R, China. summyzh@126.com.
authors.forename: Yanfeng
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D040421:Cell Phone / Q000706:statistics & numerical data*; D002681:China; D016000:Cluster Analysis; D005260:Female; D006297:Health Services Accessibility / Q000706:statistics & numerical data; D006801:Humans; D007114:Immunization / Q000379:methods* / Q000706:statistics & numerical data*; D017589:Immunization Programs / Q000379:methods* / Q000706:statistics & numerical data*; D007223:Infant; D008297:Male; D015397:Program Evaluation / Q000379:methods / Q000706:statistics & numerical data; D012423:Rural Health / Q000706:statistics & numerical data; D012424:Rural Population / Q000706:statistics & numerical data*