Mobile Texting and Lay Health Supporters to Improve Schizophrenia Care in a Resource-Poor Community in Rural China (LEAN Trial): Randomized Controlled Trial Extended Implementation
Authors: Cai Yiyuan , Gong Wenjie , He Hua , Hughes James P , Simoni Jane , Xiao Shuiyuan , Gloyd Stephen , Lin Meijuan , Deng Xinlei , Liang Zichao , He Wenjun , Dai Bofeng , Liao Jing , Hao Yuantao , Xu Dong (Roman) 
Published: December 2020

Background
Schizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our initial 6-month trial (previously reported) using mobile texting and lay health supporters, called LEAN, significantly improved medication adherence from 0.48 to 0.61 (adjusted mean 0.11, 95% CI 0.03 to 0.20, P=.007) for adults with schizophrenia living in a resource-poor village in rural China.

Objective
We explored the effectiveness of our texting program in improving participants’ medication adherence, functioning, and symptoms in an extended implementation of the intervention after its initial phase.

Methods
In an approximated stepped-wedge wait-list design randomized controlled trial, 277 community-dwelling villagers with schizophrenia were assigned 1:1 in phase 1 into intervention and wait-list control groups. The intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program. Subsequently (in the extended period), both groups received the LEAN intervention plus the 686 Program. The primary outcome was antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts). The secondary outcomes were symptoms measured during visits to 686 Program psychiatrists using the Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0. Other outcomes included data routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intention-to-treat analysis and missing data were imputed. A generalized estimating equation model was used to assess program effects on antipsychotics medication adherence, symptoms, and functioning.

Results
Antipsychotics medication adherence improved from 0.48 in the control period to 0.58 in the extended intervention period (adjusted mean difference 0.11, 95% CI 0.04 to 0.19; P=.004). We also noted an improvement in symptoms (adjusted mean difference –0.26, 95% CI –0.50 to –0.02; P=.04; Cohen d effect size 0.20) and a reduction in rehospitalization (0.37, 95% CI 0.18 to 0.76; P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41). There was no improvement in functioning (adjusted mean difference 0.02, 95% CI –0.01 to 0.06; P=.18; Cohen d effect size 0.04).

Conclusions
In an extended implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective than the 686 Program alone in improving medication adherence, improving symptoms, and reducing rehospitalization.

Trial Registration
Chinese Clinical Trial Registry; ChiCTR-ICR-15006053 https://tinyurl.com/y5hk8vng