NL-OMON54253已完成不适用
SabiliTy and FeAsiBILIty of a personalised, web-based Education and self-management approach for patients with chronic Heart Failure across four European sites - STABILISE HF
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •Adults (>=18 years) that own a device where SanaCoach heart failure can be
- •Diagnosis of chronic heart failure according to ESC 2016 guidelines (HFrEF =
- •LVEF <40%, HFmrEF = LVEF 40-49%, HFpEF = LVEF >= 50%), based on
- •echocardiographic or MRI findings within the last year or considered stable
- •Ability and willingness to give written informed consent and to comply with
- •the requirements of the study
- •UPDATE-HF sub study:
- •Patient's inclusion criteria
- •Be enrolled in the STABILISE-HF study
- •Patient may not already use SanaCoach or have used it in the past
- •Willingness to have the interview recorded and transcribed
- •Sufficient Dutch language skills to answer questions
- •Ability and willingness to give written informed consent and to comply with
- •the requirements of the study
- •Patient*s relatives/informal caregivers inclusion criteria
- •Relative/informal caregiver of a patient diagnosed with HF who has already
- •been enrolled in the STABILISE-HF study
- •Adults (>=18 years)
- •Sufficient English language skills to answer questions
- •Ability and willingness to give written informed consent and to comply with
- •the requirements of the study
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Patients without access to a device where SanaCoach heart failure can be used
- •Uncontrolled or serious disease, or any medical or surgical condition, that
- •may either interfere with participation in the clinical study, and/or put the
- •subject at significant risk (according to investigator's judgment) if he/she
- •participates in the clinical study.
- •Patients that have been hospitalised for heart failure within the last 30
- •An underlying known disease, or surgical, physical, or medical condition
- •that, in the opinion of the investigator might interfere with interpretation of
- •the clinical study results.
- •Treatment with other investigational products or devices within 30 days or
- •five half-lives of the screening visit, whichever is longer.
- •Planned use of other investigational products or devices during the course of
- •Any condition that according to the investigator could interfere with the
- •conduct of the study, such as but not limited to:
- •a. Subjects who are unable to communicate or to cooperate with the
- •investigator.
- •b. Unable to understand the protocol requirements, instructions and
- •study-related restrictions, the nature, scope, and possible consequences of the
- •c. Unlikely to comply with the protocol requirements, instructions, and
- •study-related restrictions (eg, uncooperative attitude, inability to return for
- •follow-up visits (as parts of standard care), and improbability of completing
- •the study).
- •d. Have any medical or surgical condition, which in the opinion of the
- •investigator would put the subject at increased risk from participating in the
- •e. Persons directly involved in the conduct of the study.
研究者
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