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

Last updated: April 16, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

SanaCoach Heart failure

Clinical Study ID

NCT04699253
NL75892.068.20
NWE702
  • Ages > 18
  • All Genders

Study 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 heart failure. SanaCoach heart failure provides patient education, systematic self-monitoring, a care plan repository and facilitates correspondence with patient's care provider.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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 MRIfindings within the last year or considered stable before.
  • Ability and willingness to give written informed consent and to comply with therequirements of the study

Exclusion

Exclusion Criteria: 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 eitherinterfere with participation in the clinical study, and/or put the subject atsignificant risk (according to investigator's [or delegate] judgment) if he/sheparticipates 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 theopinion of the investigator (or delegate) might interfere with interpretation of theclinical study results.
  • Treatment with other investigational products or devices within 30 days or fivehalf-lives of the screening visit, whichever is longer.
  • Planned use of other investigational products or devices during the course of thestudy.
  • Any condition that according to the investigator could interfere with the conduct ofthe 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-relatedrestrictions, the nature, scope, and possible consequences of the study.
  • c. Unlikely to comply with the protocol requirements, instructions, and study-relatedrestrictions (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 investigatorwould put the subject at increased risk from participating in the study
  • e. Persons directly involved in the conduct of the study.

Study Design

Total Participants: 542
Treatment Group(s): 1
Primary Treatment: SanaCoach Heart failure
Phase:
Study Start date:
July 01, 2021
Estimated Completion Date:
December 31, 2023

Study 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 provider to optimise health outcomes and quality of life.

Consented study participants meeting the eligibility criteria for the STABILISE HF study will be using the the "SanaCoach heart failure" during a 6-month study period. SanaCoach heart failure is an application on the internet that supports patients and care providers in the development, implementation and monitoring of patient self-management. The SanaCoach heart failure provides information about heart failure, treatment, and lifestyle modifications. It can also monitor the patient's wellbeing, symptoms, vital signs, and gives advice on whether review with a health care provider is advisable. Furthermore, it provides a repository for patient's care plan to give insight into the course and treatment of the disorder.

Recruitment and dropout statistics will be assessed and the sociodemographic and comorbidity profile of consenting study participants as well as consenting non-participants (Patients who decide not to participate will be given an option to complete an anonymous sociodemographic survey.) will be analysed.

Connect with a study center

  • University Hospital Aachen

    Aachen,
    Germany

    Site Not Available

  • St. Michael's Hospital Dublin

    Dublin,
    Ireland

    Site Not Available

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Site Not Available

  • Royal Victoria Hospital Belfast

    Belfast,
    United Kingdom

    Site Not Available

  • University of Suffolk

    Ipswich,
    United Kingdom

    Site Not Available

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