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临床试验/NCT05951088
NCT05951088招募中不适用

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Long-term adherence

研究概览

简要总结

This trial has to aim to evaluate an innovative, in-house developed mobile application supporting patients in their home environment by actively involving them in different aspects of their condition and treatment. The usability, long-term adherence and patient satisfaction will be studied in patients with atrial fibrillation (AF) and/or heart failure (HF).

详细描述

Atrial fibrillation (AF) and heart failure (HF) are global cardiovascular disease epidemics associated with significant morbidity and mortality. Their prevalence is already high and will continue to increase in the coming decades. A structured and efficient care system encompassing various aspects is needed to manage AF and HF morbidity and mortality. Technological developments and the increased use of smart devices, including in medical care, create opportunities to implement mobile applications to provide continuous, high-quality follow-up to patients. Our in-house developed application, recently improved and expended, provides a reliable source of educational material on AF and HF, with the ability to save health appointments, enter measurements (such as heart rate, blood pressure, weight) and keep a medication list (including notifications when medication should be taken). In addition, the application includes questionnaires to assess, for example, patients' knowledge, selfcare, quality of life, physical activity and symptoms. The application allows personalisation per patient depending on the clinical setting and indication. The innovative application will be evaluated in terms of usability, long-term adherence and patient satisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years,
  • Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, Holter monitor,…) and/or patients in whom HF is diagnosed in their medical records,
  • Patients who are capable of signing the informed consent.

排除标准

  • Not able to speak and read Dutch,
  • Cognitive impaired (e.g. severe dementia),
  • No smartphone or tablet available.

结局指标

主要结局

Long-term adherence

时间窗: From date of randomization until end of study, assessed up to 36 months

Long-term adherence will be measured using the app user data

Usability of the application

时间窗: Change of usabilitiy of the application from baseline to12 months

Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.

Patient satisfaction with the application-driven follow-up

时间窗: Change from baseline patient satisfaction with the application to 3- and 12 months

Patient satisfaction will be evaluated during the follow-up period using a specific 'Satisfaction Questionnaire'.

次要结局

  • Disease specific self-care management(Change from baseline to 3 and 12 months)
  • Disease specific Knowledge(Change from baseline to 1, 3, 6, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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