Medizinische Klinik und Poliklinik 1, LMU Klinikum der Universität München, Munich, Germany.
DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, LMU Klinikum der Universität München, Munich, Germany.
BMJ Open. 2024 Sep 5;14(9):e081347. doi: 10.1136/bmjopen-2023-081347.
Hypertension is a major cause of premature death worldwide as it is an important risk factor for coronary artery disease, myocardial infarction, heart failure and stroke. Although an estimated 1.3 billion adults suffer from hypertension, less than half of them are diagnosed correctly and therefore receive sufficient treatment. Furthermore, only one fifth of those treated reach the therapy target of normotension. This significant deficit underlines the need for new therapy concepts to improve long-term health outcomes. Several studies have shown positive effects of digital health programmes in the disease management of ambulatory, long-term hypertension treatment. More research is needed to explore the abilities of digital health programmes as an innovative pathway in ambulatory healthcare.The eXPLORE study aims to evaluate the feasibility of a clinical trial on the impact of a supplementary digital therapy programme for the treatment of primary arterial hypertension.
The eXPLORE study collects data in the setting of a prospective randomised controlled trial to evaluate methodological feasibility for larger-scaled follow-up research. The study compares a digital therapy programme using a smartphone application that is based on functions and algorithms creating tasks and recommendations based on individual health data to standard care for the treatment of primary arterial hypertension. The study period is 180 days, with a 90-day in-life phase followed by a 90-day follow-up phase. Baseline and follow-up data (3 months, 6 months follow-up) of all participants included is collected via questionnaire surveys as well as self-administered blood pressure monitoring. Patient inclusion, initial data acquisition and follow-up were carried out in an innovative remote setting. The study was initiated in November 2022 and is currently ongoing. Study outcome measures are changes in mean blood pressure, health literacy and self-sufficient health behaviour.
The eXPLORE study is carried out in accordance with all applicable legal regulations. Cost-effectiveness is assured by continuous evaluation and documentation over the course of the study. All health-relevant data from the eXPLORE study will be provided for analyses and publication to the investigators of LMU Hospital. The study was approved by the local ethics committee of LMU Munich (project nr.: 22-0115).
NCT05580068.
1.5, 28.08.2023.
高血压是全球范围内导致过早死亡的主要原因，因为它是冠状动脉疾病、心肌梗死、心力衰竭和中风的重要危险因素。尽管估计有 13 亿成年人患有高血压，但其中不到一半的人得到了正确诊断并因此接受了足够的治疗。此外，只有五分之一接受治疗的人达到了正常血压的治疗目标。这种显著的不足凸显了需要新的治疗概念来改善长期健康结果。一些研究表明，数字健康计划在门诊、长期高血压治疗的疾病管理中具有积极作用。需要更多的研究来探索数字健康计划作为门诊医疗保健创新途径的能力。eXPLORE 研究旨在评估补充数字治疗计划对原发性高血压治疗的影响的临床试验的可行性。
eXPLORE 研究在一项前瞻性随机对照试验的背景下收集数据，以评估更大规模后续研究的方法学可行性。该研究比较了一种使用智能手机应用程序的数字治疗计划，该应用程序基于基于个人健康数据创建任务和建议的功能和算法，与原发性动脉高血压治疗的标准护理进行比较。研究期为 180 天，包括 90 天的生活期和 90 天的随访期。所有参与者的基线和随访数据（3 个月、6 个月随访）通过问卷调查和自我管理血压监测收集。患者纳入、初始数据采集和随访均在创新的远程环境中进行。该研究于 2022 年 11 月启动，目前正在进行中。研究结果衡量指标是平均血压、健康素养和自我保健行为的变化。
eXPLORE 研究符合所有适用的法律规定。通过在研究过程中的持续评估和记录，确保成本效益。eXPLORE 研究的所有健康相关数据都将提供给 LMU 医院的研究人员进行分析和发表。该研究已获得 LMU 慕尼黑当地伦理委员会的批准（项目编号：22-0115）。
NCT05580068。
1.5，2023 年 8 月 28 日。
