Evaluating a Digital Health Application for Post-stroke Care and Vascular Risk Factor Management - a Multicenter Randomized Controlled Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VASCage GmbH
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Health-related quality of life (EQ VAS)
研究概览
简要总结
Stroke is a leading cause of death and long-term disability worldwide. Despite substantial advances in acute stroke care, there remains a lack of evidence-based digital solutions to support patients after hospital discharge. This study evaluates the effectiveness of a digital health application (StrokeApp) designed to support patients with ischemic or hemorrhagic stroke or transient ischemic attack (TIA) in secondary prevention and recovery.
In this multicenter, randomized, controlled, open-label trial, 500 patients will be assigned in a 1:1 ratio to receive either standard care alone or standard care in combination with StrokeApp. The primary objective is to assess the impact of the application on health-related quality of life three months after discharge. Secondary and exploratory outcomes include health literacy, medication adherence, vascular risk factors, health-related behaviors, psychosocial outcomes, long-term recovery up to twelve months, as well as safety and user experience.
详细描述
This study evaluates the clinical effectiveness, usability, and safety of a digital health application (StrokeApp) designed to support patients following ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) during the post-acute phase of care.
The StrokeApp is a mobile medical application classified as a Class IIa medical device and is currently in the pivotal phase of clinical development. It is intended to complement standard care by supporting secondary prevention and self-management. Core functionalities include the provision of structured educational content, medication and appointment reminders, tools for documenting health-related parameters, and the collection of electronic patient-reported outcomes (ePROs). In addition, the application offers optional tracking features and automated feedback to support adherence to recommended health behaviors.
The study is conducted as a multicenter, randomized, controlled, open-label clinical trial. Participants are enrolled during hospitalization for the index event and randomized in a 1:1 ratio to receive either standard care alone or standard care in combination with StrokeApp. The application is installed on the participant's personal mobile device during the hospital stay. Participants receive structured onboarding, including training on core functionalities and data entry. A reinforcement session is conducted prior to discharge to ensure independent use.
Following discharge, participants in the intervention group use the application over a period of up to twelve months. During this time, they are prompted to complete ePROs at predefined intervals and may optionally use daily tracking functions. The application delivers reminders, educational material, and automated feedback based on user input. Technical support is available throughout the study period if needed.
Study procedures and follow-up assessments are aligned with routine clinical practice. Data are collected through a combination of on-site visits, remote contacts, and electronic questionnaires. Participants in the control group follow the same visit schedule but complete patient-reported outcomes using web-based tools rather than the application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient (biological sex) ≥18 years at the time of consent
- •Hospitalization for acute ischemic stroke, acute haemorrhagic stroke or TIA
- •Necessary Technical Equipment (smartphone or tablet computer) and skills
- •Able to provide informed consent
排除标准
- •Cerebral infarction due to cerebral venous thrombosis (CVT)
- •Severe Psychiatric Conditions
- •Severe pre-existing cognitive impairment
- •Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) or other patients where salt restriction is harmful.
- •Inability to operate the device independently (assistance from a caregiver is acceptable). E.g.:
- •Severe apraxia,
- •Severe Motor Disabilities,
- •Severe Visual Impairment
- •Severe Communication Barriers (e.g. Severe Aphasia, Severe Dysarthria)
- •Inability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.
- •Women of childbearing potential not willing to adopt effective contraceptive measures during the clinical investigation
- •Patients who are considered to be part of the vulnerable population:
- •Persons unable to give consent
- •Persons performing military service
- •persons detained by court or official order or accommodated in accordance with the Accommodation Act, Federal Law Gazette No. 155/1990
- •Pregnant or breastfeeding women
研究组 & 干预措施
Standard Care + StrokeApp
Participants receive standard post-stroke care in accordance with clinical guidelines plus access to the StrokeApp. The application is installed during hospitalization and includes structured onboarding. It provides educational content, medication and appointment reminders, electronic patient-reported outcomes (ePROs), and optional tracking of health-related parameters. Participants may use the app for up to 12 months following discharge and receive automated feedback and reminders to support secondary prevention and self-management.
干预措施: StrokeApp (Device)
Standard Care
Participants receive standard post-stroke care in accordance with clinical guidelines, including routine outpatient follow-up. Participants complete study-related assessments, including patient-reported outcomes, via web-based tools but do not have access to the StrokeApp.
干预措施: Standard care (Other)
结局指标
主要结局
Health-related quality of life (EQ VAS)
时间窗: 3 months after hospital discharge
Health-related quality of life measured using the EQ Visual Analogue Scale (EQ VAS), a standardized instrument assessing the participant's self-rated health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
次要结局
- Self-perceived stress (PPS-10)(Secondary outcome parameters will be assessed at 3 months.)
- LDL-cholesterol levels(Secondary outcome parameters will be assessed at 3 months.)
- Health literacy (HLS19-Q12)(Secondary outcome parameters will be assessed at 3 months.)
- The adherence to medication (MARS-D).(Secondary outcome parameters will be assessed at 3 months.)
- HbA1c levels below 7.5% in patients with diabetes at baseline(Secondary outcome parameters will be assessed at 3 months.)
- Average systolic office blood pressure level(Secondary outcome parameters will be assessed at 3 months.)
- Physical activity (IPAQ)(Secondary outcome parameters will be assessed at 3 months.)
- Number of cigarettes smoked per day(Secondary outcome parameters will be assessed at 3 months.)
- Diet (MEPA)(Secondary outcome parameters will be assessed at 3 months.)
- Alcohol consumption (AUDIT-C)(Secondary outcome parameters will be assessed at 3 months.)
- Sleep quality (VAS)(Secondary outcome parameters will be assessed at 3 months.)
- Average hours of sleep per night (self-reported)(Secondary outcome parameters will be assessed at 3 months.)
- Symptoms of Anxiety (HADS-A)(Secondary outcome parameters will be assessed at 3 months.)
- Symptoms of Depression (HADS-D)(Secondary outcome parameters will be assessed at 3 months.)
- The patient's return to life after discharge (questionnaire) at 3 months.(Secondary outcome parameters will be assessed at 3 months.)
- Fatigue (VAS)(Secondary outcome parameters will be assessed at 3 months.)
- Overall quality of life (VAS)(Secondary outcome parameters will be assessed at 3 months.)
- Health related quality of life (EQ-5D-3L overall health utility score calculated from individual 3-level components using rescaled European visual analogue scale weights)(Secondary outcome parameters will be assessed at 3 months.)