Sun Yat-sen Global Health Institute, School of Public Health and Institute of National Governance, Sun Yat-sen University, Guangzhou, Guangdong, China.
Xiangya School of Public Health, Central South University, Changsha, Hunan, China.
PLoS Med. 2019 Apr 23;16(4):e1002785. doi: 10.1371/journal.pmed.1002785. eCollection 2019 Apr.
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.
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.
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.
Chinese Clinical Trial Registry ChiCTR-ICR-15006053.
精神分裂症是导致残疾的主要原因,为了应对中低收入国家精神卫生保健资源方面的挑战,人们提出了从机构护理向社区护理转变。我们假设,与单纯的社区免费药物治疗方案相比,在资源匮乏的社区环境中增加手机短信服务,将改善精神分裂症患者的护理。
这是一项 2 臂随机对照试验,从中国湖南省的 9 个乡镇随机选择了 278 名居住在社区的村民(患者参与者),并按照 1:1 的比例随机分为 2 组。该方案的参与者于 2015 年 5 月 1 日至 8 月 31 日招募,干预和随访于 2015 年 12 月 15 日至 2016 年 7 月 1 日进行。两组的基线特征相似。患者平均年龄为 46 岁,接受了 7 年的教育,患有精神分裂症 18 年,症状轻微,功能障碍程度较低,近五分之一的患者丧失了功能,主要与家人一起生活(95%),收入较低。干预组和对照组都接受了全国性的社区心理健康项目,该项目提供免费的抗精神病药物。干预组的患者参与者还接受了 LEAN(非专业卫生支持者、电子平台、奖励和整合),该方案的特点是招募非专业卫生支持者并发送短信提醒服药、健康教育、监测早期复发迹象以及促进与初级保健的联系。主要结局是通过两次相隔 30 天的家庭用药记录评估用药依从性(服用剂量的比例),在 6 个月的终点进行评估。次要和其他结局包括患者症状、功能、复发、再住院、任何原因导致的死亡、未经通知擅自离开、对他人的暴力行为、破坏物品和自杀。采用意向治疗分析。缺失数据采用多重插补处理。共有 278 名患者参与者中的 271 名成功完成了结局评估。对照组的用药依从性为 0.48,干预组为 0.61(调整后的平均差异[AMD]为 0.12[95%置信区间 0.03 至 0.22];p=0.013;效应量 0.38)。在次要和其他结局中,我们注意到复发风险显著降低(26[21.7%]的 120 名干预组参与者与 40[34.2%]的 117 名对照组参与者;相对风险 0.63[95%置信区间 0.42 至 0.97];需要治疗的人数[NNT]8.0)和再住院率(9[7.3%]的 123 名干预组参与者与 25[20.5%]的 122 名对照组参与者;相对风险 0.36[95%置信区间 0.17 至 0.73];NNT 7.6)。该方案在所有其他结局方面均无统计学差异。在该方案实施过程中,干预组有 2 名参与者和对照组有 1 名参与者死亡。该研究的局限性包括缺乏完整的经济分析、短信内容缺乏个体化定制、随访时间相对较短以及中国背景下的推广限制。
在资源匮乏的社区环境中,为患者及其非专业卫生支持者增加短信服务,比单纯的免费药物治疗方案更能提高用药依从性,减少复发和再住院。未来的研究可能会测试针对个体患者的短信定制的有效性。
中国临床试验注册中心 ChiCTR-ICR-15006053。