Lay health supporters aided by mobile text messaging to improve adherence, symptoms, and functioning among people with schizophrenia in a resource-poor community in rural China (LEAN): A randomized controlled trial

Background Schizophrenia is a leading cause of disability, and a shift from facility- to community-based care has been proposed to meet the resource challenges of mental healthcare in low- and middle-income countries. We hypothesized that the addition of mobile texting would improve schizophrenia care in a resource-poor community setting compared with a community-based free-medicine program alone. Methods and findings In this 2-arm randomized controlled trial, 278 community-dwelling villagers (patient participants) were randomly selected from people with schizophrenia from 9 townships of Hunan, China, and were randomized 1:1 into 2 groups. The program participants were recruited between May 1, 2015, and August 31, 2015, and the intervention and follow-up took place between December 15, 2015, and July 1, 2016. Baseline characteristics of the 2 groups were similar. The patients were on average 46 years of age, had 7 years of education, had a duration of schizophrenia of 18 years with minimal to mild symptoms and nearly one-fifth loss of functioning, and were mostly living with family (95%) and had low incomes. Both the intervention and the control groups received a nationwide community-based mental health program that provided free antipsychotic medications. The patient participants in the intervention group also received LEAN (Lay health supporters, E-platform, Award, and iNtegration), a program that featured recruitment of a lay health supporter and text messages for medication reminders, health education, monitoring of early signs of relapses, and facilitated linkage to primary healthcare. The primary outcome was medication adherence (proportion of dosages taken) assessed by 2 unannounced home-based pill counts 30 days apart at the 6-month endpoint. The secondary and other outcomes included patient symptoms, functioning, relapses, re-hospitalizations, death for any reason, wandering away without notifying anyone, violence against others, damaging goods, and suicide. Intent-to-treat analysis was used. Missing data were handled with multiple imputations. In total, 271 out of 278 patient participants were successfully followed up for outcome assessment. Medication adherence was 0.48 in the control group and 0.61 in the intervention group (adjusted mean difference [AMD] 0.12 [95% CI 0.03 to 0.22]; p = 0.013; effect size 0.38). Among secondary and other outcomes we noted substantial reduction in the risk of relapse (26 [21.7%] of 120 interventional participants versus 40 [34.2%] of 117 controls; relative risk 0.63 [95% CI 0.42 to 0.97]; number needed to treat [NNT] 8.0) and re-hospitalization (9 [7.3%] of 123 interventional participants versus 25 [20.5%] of 122 controls; relative risk 0.36 [95% CI 0.17 to 0.73]; NNT 7.6). The program showed no statistical difference in all other outcomes. During the course of the program, 2 participants in the intervention group and 1 in the control group died. The limitations of the study include its lack of a full economic analysis, lack of individual tailoring of the text messages, the relatively short 6-month follow-up, and the generalizability constraint of the Chinese context. Conclusions The addition of texting to patients and their lay health supporters in a resource-poor community setting was more effective than a free-medicine program alone in improving medication adherence and reducing relapses and re-hospitalizations. Future studies may test the effectiveness of customization of the texting to individual patients. Trial registration Chinese Clinical Trial Registry ChiCTR-ICR-15006053.
Wenjie Gong and colleagues show that mobile messaging can increase medication adherence and reduce relapses in schizophrenia patients in rural China.
Author summary Why was this study done? Schizophrenia is a leading cause of disability, but in low- and middle-income countries (LMICs) the treatment gap remains high, and even when treatment is available, adherence to antipsychotics is low. Mobile text messaging has been shown to be useful to strengthen community- and family-based care in resource-poor settings due to its availability, reliability, and ease of use. However, there has been no clear evidence that texting improves treatment adherence, symptoms, and functioning in people with schizophrenia. What did the researchers do and find? We developed an intervention called LEAN, involving the recruitment of lay health supporters; an electronic platform with mobile texting for medication reminders, health education, and monitoring; the awarding of token gifts for positive behavioral improvement, and integration of the texting with the health system. In this 2-arm randomized controlled trial, the control group received a free antipsychotic medication program (the 686 Program) while the intervention group received the 686 Program plus LEAN. We found significant improvement in medication adherence (0.48 in the control group versus 0.61 in the intervention group) and a substantial reduction in the risks of relapse and re-hospitalization with the intervention. What do these findings mean? LEAN demonstrated a 27% improvement in adherence, which is larger than the 15%–18% range reported in other text message interventions. Two unique features may have contributed to the relative superiority of LEAN: active engagement of lay health supporters and the use of texting to connect the entire treatment team from patients to lay health supporters to village doctors to psychiatrists, all in support of the patient. Texting effectively addressed the low adherence at marginal cost, and LEAN’s experiences may be useful for other LMICs with resource constraints. However, an adaptation of LEAN should fully consider some implementation details including keeping the program simple and integrated into routine care, maintaining low cost, and choosing existing texting platforms if available.