Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jul 18, 2020
Date Accepted: Oct 29, 2020
Mobile texting and lay health supporters to improve schizophrenia care in a resource-poor community in rural China（LEAN trial）: an extended implementation of a randomized controlled trial
ABSTRACT
Background:
Schizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our 6-month trial using mobile texting and lay health supporters (LEAN) significantly improved medication adherence (percentage of dosages taken) (but not functioning and symptoms) from 0.48 to 0.61 (the adjusted mean difference [AMD] 0.11 [95%CI: 0.03 to 0.20], P=0.0071) at post-intervention for villagers with schizophrenia in a resource-poor community setting 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 this wait-listed design randomized controlled trial(RCT), 277 community-dwelling villagers with schizophrenia were assigned 1:1 in Phase 1 into intervention and wait-list control groups. The intervention group received “LEAN” intervention includes (1) Lay health supporters (medication/care supervisors), (2) E-platform (mobile-texting reminders and education message), (3) Award (a token gift for positive behavioral changes) and (4) iNtegration (integration with the existing government community-mental health program (the 686 Program). The wait-list control group received the 686 Program only. In the extended intervention period, both intervention and wait-listed control groups received the 686 Program plus our intervention, which approximated a stepped-wedge RCT. 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 participants’ symptoms measured with Clinical Global Impression for schizophrenia (CGI-Sch) during their visits to the 686 Program psychiatrists, functioning measured with WHO Disability Assessment Schedule 2.0 (WHODAS) by trained student assessors. Other outcomes included routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intent-to-treat analysis and missing data were dealt with multiple imputations. The generalized estimating equation model was used to assess program effects on antipsychotics adherence, symptoms, and functioning.
Results:
In the extended intervention period, antipsychotics adherence improved from 0.48 in the control period to 0.58 in the intervention period (AMD: 0.11 [95%CI: 0.04-0.19]), P=0.0039). We also noted an improvement in symptoms (AMD: -0.26, P=0.0349) and a reduction in re-hospitalization (RR: 0.58, P=0.0226). There was no improvement in functioning and other outcomes.
Conclusions:
In a longer-term implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective to improve medication adherence, symptoms, and re-hospitalization than the 686 Program alone. Clinical Trial: The trial was prospectively registered on the Chinese Clinical Trial Registry (ChiCTR-ICR-15006053).
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