Usability and Feasibility of a Personalized, Web-based Education and Self-management Approach for Patients With Chronic Heart Failure Across Four European Sites

Korábbi kezelés

• 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 the study.

Más betegség

• Patients without access to a device where SanaCoach heart failure can be used on
• 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 [or delegate] judgment) if he/she participates in the clinical study.
• Patients that have been hospitalised for heart failure within the last 30 days.
• An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
• Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
• 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 study

Egyéb

• Patients meeting any of the following criteria are NOT eligible for this study
• 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 study.
• c. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
• e. Persons directly involved in the conduct of the study.

• Patients must meet ALL of the following criteria in order to be eligible for this study.
• Adults (≥18 years) that own a device where SanaCoach heart failure can be used on
• 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 before.
• Ability and willingness to give written informed consent and to comply with the requirements of the study