Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.
Curelator Inc., Cambridge, MA, 02139, USA.
Trials. 2022 May 11;23(1):382. doi: 10.1186/s13063-022-06329-2.
Overall, 55% of the German population suffers from primary episodic headaches according to recent studies. Inadequate management of headache disorders is a significant medical problem. The prevalence of medication overuse headache (MOH) is about 1% with an estimated number of 800,000 people in Germany. Medication overuse (MO) and MOH are usually managed through a complex process of medication withdrawal and initiating of prophylaxis. However, patients who were successfully treated for MO or MOH have a high relapse rate in the following 2 years. Previously, continued monitoring of self-reported medication intake demonstrated lower relapse rates. The prevalence and burden of MO and MOH are high, and effective strategies to prevent the development of a relapse into MOH or de novo MOH are still missing. Therefore, the MOH trial was designed to assess the effects of combining self-reported medication intake with daily monitoring of the entered data and a personalized patient-specific medication intake feedback system in an easy-accessible app-based platform in order to prevent the development and relapse of MO(H).
The MOH trial is a randomized, controlled, parallel, multicenter, prospective trial. A total of 624 migraine patients with frequent migraine attacks and 336 patients who underwent treatment for MO(H) will be randomly allocated to use either a customized app with or without individual feedback regarding their self-reported medication intake for 12 months. The primary outcome will be the proportion of patients developing MO or MOH for at least 3 consecutive months between baseline and end of study visits.
This trial will assess the effects of providing patients with feedback regarding their self-reported use of migraine medications and migraine days using a mobile software on the development or prevention of MO(H). We hypothesize that the development of MO(H) in patients with frequent episodic migraine (EM) or chronic migraine (CM) and relapse after treatment of MO(H) can be reduced by a feedback system. If this trial proves that using an app with specific and unspecific messaging to the patient is successful, this method, which is now investigated mainly in specialized headache centers, could later be extended to primary care, thus providing benefits for a broader patient group.
German Clinical Trials Register DRKS00025961 . Registered on 04 August 2021.
根据最近的研究，55%的德国人口患有原发性发作性头痛。头痛疾病管理不善是一个严重的医学问题。药物过度使用性头痛（MOH）的患病率约为 1%，德国估计有 80 万人患有这种疾病。药物过度使用（MO）和 MOH 通常通过药物戒断和启动预防治疗的复杂过程来治疗。然而，成功治疗 MO 或 MOH 的患者在接下来的 2 年内复发率很高。以前，继续监测自我报告的药物摄入量显示出较低的复发率。MO 和 MOH 的患病率和负担都很高，仍然缺乏预防 MOH 或新发 MOH 发展的有效策略。因此，设计了 MOH 试验，以评估结合自我报告的药物摄入、每天监测输入的数据以及基于易于访问的应用程序平台的个性化患者特定药物摄入反馈系统来预防 MO(H)的发展和复发的效果。
MOH 试验是一项随机、对照、平行、多中心、前瞻性试验。共有 624 名偏头痛发作频繁的偏头痛患者和 336 名接受 MO(H)治疗的患者将被随机分配使用定制的应用程序，该应用程序具有或不具有关于他们自我报告的药物摄入的个人反馈，为期 12 个月。主要结局将是在基线和研究结束访视之间至少连续 3 个月出现 MO 或 MOH 的患者比例。
本试验将评估为患者提供关于他们自我报告的偏头痛药物使用和偏头痛天数的反馈使用移动软件对 MO(H)的发展或预防的效果。我们假设通过反馈系统可以减少频繁发作性偏头痛（EM）或慢性偏头痛（CM）患者 MO(H)的发展和 MO(H)治疗后的复发。如果该试验证明使用针对特定和非特定患者的应用程序是成功的，这种方法现在主要在专门的头痛中心进行研究，以后可以扩展到初级保健，从而为更广泛的患者群体带来益处。
德国临床试验注册处 DRKS00025961。于 2021 年 8 月 4 日注册。
