title: Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial.
abstract: BACKGROUND
  Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings.
  
  
  METHODS
  The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic '686' Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach.
  
  
  BACKGROUND
  University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on FigShare.
  
  
  BACKGROUND
  ChiCTR-ICR-15006053; Pre-results.
authors.affiliation: Sun Yat-sen Global Health Institute (SGHI), School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China Department of Global Health, University of Washington, Seattle, Washington, USA.
authors.forename: Dong Roman
authors.identifier: http://orcid.org/0000-0001-7438-632X
authors.initials: DR
authors.lastname: Xu
authors.affiliation: Xiangya School of Public Health, Central South University, Changsha, Hunan, China Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA.
authors.forename: Wenjie
authors.initials: W
authors.lastname: Gong
authors.affiliation: Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Caine
authors.affiliation: Xiangya School of Public Health, Central South University, Changsha, Hunan, China.
authors.forename: Shuiyuan
authors.initials: S
authors.lastname: Xiao
authors.affiliation: Department of Biostatistics, University of Washington, Seattle, Washington, USA.
authors.forename: James P
authors.initials: JP
authors.lastname: Hughes
authors.affiliation: Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Ng
authors.affiliation: Department of Phycology, University of Washington, Seattle, Washington, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Simoni
authors.affiliation: Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.
authors.forename: Hua
authors.initials: H
authors.lastname: He
authors.affiliation: Division of Health Promotion and Behavioral Sciences, University of Texas Health Science Center School of Public Health at Houston, Houston, Texas, USA.
authors.forename: Kirk L
authors.initials: KL
authors.lastname: Smith
authors.affiliation: Austin Regional Campus Michael & Susan Dell Center for Healthy Living, UTHealth School of Public Health, Austin, Texas, USA.
authors.forename: Henry Shelton
authors.initials: HS
authors.lastname: Brown
authors.affiliation: Department of Global Health, University of Washington, Seattle, Washington, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Gloyd
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D017028:Caregivers; D040421:Cell Phone; D002681:China; D002985:Clinical Protocols; D006801:Humans; D008507:Medically Underserved Area; D055118:Medication Adherence; D058996:Quality Improvement; D019035:Rural Health Services / Q000458:organization & administration / Q000592:standards; D012559:Schizophrenia / Q000188:drug therapy*; D017216:Telemedicine / Q000379:methods; D060145:Text Messaging
chemical_list: D014150:Antipsychotic Agents
keywords: implementation science; lay health worker; mHealth; medication adherence; schizophrenia; “686” program