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

NCT04699253 | Completed

• 2 other identifiers: NL75892.068.20NWE702
• Study Type: observational
• Target: 542
• Locations: 4 countries
• Sites: 5

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

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; patient self-management; patient education; web application

Outcome Measures

Primary Outcomes (1)

• Usability of the SanaCoach heart failure

  • Score on the System Usability Scale (SUS)

  Baseline to 6 months

Secondary Outcomes (5)

• Usability

  Baseline to 6 months

• Feasibility of the SanaCoach heart failure

  Baseline to 6 months

• Acceptability

  Baseline to 6 months

• Adherence rates

  Baseline to 6 months

• Technology readiness index (TRI)

  Baseline to 6 months

Other Outcomes (5)

• Effectiveness

  Baseline to 6 months

• Medication adherence

  Baseline to 6 months

• Quality of life assessment

  Baseline to 6 months

Study Arms (2)

Consenting participants

Patients meeting the eligibility criteria and are using the SanaCoach heart failure during the study period.

Device: SanaCoach Heart failure

Consenting non-participants

Patients meeting the eligibility criteria but do not wish to use the SanaCoach heart failure and only fill-in an anonymized questionnaire once, without any follow-up.

Interventions

SanaCoach Heart failure DEVICE

Patients will be using the SanaCoach heart failure for at least 6 months during the study period. SanaCoach heart failure is a web application that will be guiding the patient through a regular, systematic assessment of patient's health and wellbeing as well as regular education sessions. The assessment frequency ranges from daily to monthly, based on the settings provided by the health care provider. Furthermore, it provides a repository for patient's care plan to give insight into the course and treatment of the disorder and offers the possibility to contact the health care provider through the web application.

Consenting participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ambulatory heart failure patients evaluated in 4 different European sites

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• RWTH Aachen University: collaborator
• Queen's University, Belfast: collaborator
• University College Dublin: collaborator

Study Sites (5)

University Hospital Aachen

Aachen, Germany

Location

St. Michael's Hospital Dublin

Dublin, Ireland

Location

Maastricht UMC+

Maastricht, Netherlands

Location

Royal Victoria Hospital Belfast

Belfast, United Kingdom

Location

University of Suffolk

Ipswich, United Kingdom

Location

Related Publications (1)

• Gingele AJ, Amin H, De Wit K, Jacobsen M, Hageman A, van der Mierden K, Brandts J, Weerts J, Barrett M, Dixon LJ, Hill L, Knackstedt C, Brunner-La Rocca HP. Developing an artificial intelligence-based decision engine for disease-modifying therapy in heart failure: a pilot study. Eur Heart J Digit Health. 2023 Dec 1;6(2):285-288. doi: 10.1093/ehjdh/ztad075. eCollection 2025 Mar.

  PMID: 40110213 DERIVED

Study Officials

• Hans-Peter Brunner-La Rocca, Prof

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the study. Expected Q2 of 2022
• Access Criteria: Substantiated request to coordinator of the consortium with details about reason for request , which data and how the data will be used.

Locations

IE (1); GB (2); NL (1); DE (1)