SabiliTy and FeAsiBILIty of a personalised, web-based Education and self-management approach for patients with chronic Heart Failure across four European sites

Completed

• Conditions: heart failure; 10019280

• Registration Number: NL-OMON54253
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

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
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

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

Exclusion Criteria

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
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 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 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 (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
study
• e. Persons directly involved in the conduct of the study.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Score on the System Usability Scale (SUS)<br /><br><br /><br>• UPDATE-HF sub study: Qualitatively assess the usability of SanaCoach and<br /><br>acceptability from patients* perspective.</p><br>