Kamal Ayeesha Kamran, Shaikh Quratulain Nauman, Pasha Omrana, Azam Iqbal, Islam Muhammad, Memon Adeel Ali, Rehman Hasan, Affan Muhammad, Nazir Sumaira, Aziz Salman, Jan Muhammad, Andani Anita, Muqeet Abdul, Ahmed Bilal, Khoja Shariq
Neurology, Stroke Service, The International Cerebrovascular Translational Clinical Research Training Program (Fogarty International Center, National Institutes of Health) and Department of Medicine, Aga Khan University, Karachi, Pakistan.
The International Cerebrovascular Translational Clinical Research Training Program (Fogarty International Center, National Institutes of Health) and Aga Khan University, Karachi, Pakistan.
BMC Neurol. 2015 Aug 28;15:157. doi: 10.1186/s12883-015-0413-2.
Stroke is a major cause of morbidity and mortality, especially in low and middle income countries. Medical management is the mainstay of therapy to prevent recurrence of stroke. Current estimates are that only 1 in 6 patients have perfect adherence to medication schedules. Using SMS (Short Messaging Service) as reminders to take medicines have been used previously for diseases such as diabetes and HIV with moderate success. We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke.
This will be a randomized, controlled, assessor blinded single center superiority trial. Adult participants with access to a cell phone and a history of stroke longer than 1 month on multiple risk modifying medications will be selected from Neurology and Stroke Clinic. They will be randomized into two parallel groups in a 1:1 ratio via block technique with one group receiving the standard of care as per institutional guidelines while the parallel group receiving SMS reminders for each dose of medicine in addition to the standard of care. In addition intervention group will receive messages for lifestyle changes, medication information, risk factors and motivation for medication adherence. These will bemodeled on Social Cognitive Theory and Health Belief Model and will be categorized by Michies Taxonomy of Behavioral Change Communication. Patient compliance to medicines will be measured at baseline and then after 2 months in each group by using the Morisky Medication Adherence Scale. The change in compliance to medication regimen after the intervention and the difference between the two groups will be used to determine the effectiveness of SMS reminders as a tool to increase medication compliance. The acceptability of the SMS will be determined by a tool designed for this study whose attributes are based Rogers Diffusion of innovation theory. A sample size of 86 participants in each arm will be sufficient to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % between the two groups; using an attrition rate of 15 %, 200 participants in all will be randomized.
The SMS for Stroke Study will provide evidence for feasibility and effectiveness of SMS in improving post stroke medication adherence in an LMIC setting.
https://clinicaltrials.gov/ct2/show/NCT01986023 11 /11/2013.
中风是发病和死亡的主要原因，在低收入和中等收入国家尤其如此。药物治疗是预防中风复发的主要治疗方法。目前的估计是，每6名患者中只有1名能完全遵守用药计划。此前，使用短信（短消息服务）作为服药提醒已应用于糖尿病和艾滋病等疾病，并取得了一定成效。我们旨在探讨短信在提高中风患者药物依从性方面的有效性和可接受性。
这将是一项随机、对照、评估者盲法的单中心优效性试验。将从神经内科和中风诊所选取能够使用手机且有超过1个月中风病史并正在服用多种风险修正药物的成年参与者。他们将通过区组技术以1:1的比例随机分为两个平行组，一组按照机构指南接受标准治疗，而平行组除接受标准治疗外，还将收到每剂药物的短信提醒。此外，干预组将收到关于生活方式改变、药物信息、风险因素以及坚持服药动机的信息。这些信息将以社会认知理论和健康信念模型为基础，并按照米基斯行为改变沟通分类法进行分类。通过使用莫利斯基药物依从性量表，在基线时以及每组2个月后测量患者的药物依从性。干预后药物治疗方案依从性的变化以及两组之间的差异将用于确定短信提醒作为提高药物依从性工具的有效性。短信的可接受性将通过为本研究设计的工具来确定，该工具的属性基于罗杰斯创新扩散理论。每组86名参与者的样本量足以检测出两组在莫利斯基药物依从性量表上相差1分，检验效能为90%，显著性水平为5%；考虑到15%的损耗率，总共将随机分配200名参与者。
中风短信研究将为短信在低收入和中等收入国家环境中提高中风后药物依从性的可行性和有效性提供证据。
https://clinicaltrials.gov/ct2/show/NCT01986023 2013年11月11日。
