Status:
COMPLETED
Usability and Feasibility of a Personalized, Web-based Education and Self-management Approach for Patients With Chronic Heart Failure Across Four European Sites
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
RWTH Aachen University
Queen's University, Belfast
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The STABELISE-HF is an investigator initiated, international, multicentre feasibility study that will investigate the use of a web application called SanaCoach Heart failure in patients with chronic h...
Detailed Description
Patients with chronic heart failure are encouraged to self-manage their illness, such as adhering to medical regimens, monitoring symptoms and adhere to lifestyle recommendations from the health care ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients meeting any of the following criteria are NOT eligible for this study
- 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.
- 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.
- 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 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).
- 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
- e. Persons directly involved in the conduct of the study.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT04699253
Start Date
July 1 2021
End Date
December 31 2023
Last Update
April 17 2024
Active Locations (5)
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1
University Hospital Aachen
Aachen, Germany
2
St. Michael's Hospital Dublin
Dublin, Ireland
3
Maastricht UMC+
Maastricht, Netherlands
4
Royal Victoria Hospital Belfast
Belfast, United Kingdom