Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Sep 16, 2021
Open Peer Review Period: Sep 16, 2021 - Nov 11, 2021
Date Accepted: Feb 2, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
18-month Follow-up outcomes from a randomized controlled trial of mobile texting to promote schizophrenia medication adherence in rural China (LEAN trial)
ABSTRACT
Background:
Reducing the treatment gap for mental health in low-and-middle-income countries is a high priority. Even with treatment, adherence to antipsychotics is rather low. Our use of simple technology (mobile texting) significantly improved adherence for villagers with schizophrenia in resource-poor communities in rural China. But considering the resource constraint, we need to test whether the effect of those behavior-shaping interventions may be maintained even after the suspension of the intervention.
Objective:
We explored the primary outcome of adherence and other outcomes at 18-month follow-up after the intervention had been suspended.
Methods:
In phase 1 of this randomized trial, 277 villagers with schizophrenia were randomized to receive either a government community-mental health program (686 Program) or 686 Program plus LEAN (i.e., mobile-texting and lay health supporters integrated into primary care to provide medication reminders, health education, and relapse monitoring). After a 6-month intervention, both groups received only the 686 Program for 18 months (phase 2). Outcomes at both phases included antipsychotic medication adherence, symptoms, functioning, number of re-hospitalization, suicide, and violent behaviors. The adherence and functioning were assessed at the home visit by trained assessors. The symptoms were assessed with Clinical Global Impression for schizophrenia during their visits to the 686 Program psychiatrists, Other outcomes were routinely collected in the 686 Program system. We used intention-to-treat analysis and missing data were dealt with multiple imputation. The generalized estimating equation model was used to assess program effects on adherence and other effects.
Results:
In phase 1, antipsychotic adherence and re-hospitalization incidence improved significantly. However, in phase 2, the difference of mean of antipsychotic adherence ( adjusted mean difference=0.05 [95% CI: -0.06 to 0.16], P= .410; Cohen’s d effect size=0.11) and re-hospitalization incidence (relative risk 0.65 [95% CI: 0.32-1.33], P=.235; number-needed-to-treat 21.83 [95% CI: 8.30-34.69]) were no longer statistical significantly, and there were no improvement in other outcomes in either phase.
Conclusions:
LEAN as a simple community-based intervention improved care to people with schizophrenia but the continuation of the program seems necessary to maintain the effect. Clinical Trial: The trial was prospectively registered on the Chinese Clinical Trial Registry (ChiCTR-ICR-15006053).
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