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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: SanaCoach Heart failure

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 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.

• Study Type: Observational
• Enrollment (Actual): 542

Contacts and Locations

• Study Contact: Name: Hesam Amin, MD; Phone Number: +31433877097; Email: hesam.amin@mumc.nl

Study Locations

• Germany
  • Aachen, Germany
    • University Hospital Aachen
• Ireland
  • Dublin, Ireland
    • St. Michael's Hospital Dublin
• Netherlands
  • Maastricht, Netherlands
    • Maastricht UMC+
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital Belfast
  • Ipswich, United Kingdom
    • University of Suffolk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Ambulatory heart failure patients evaluated in 4 different European sites

Description

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 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 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 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consenting participants; Patients meeting the eligibility criteria and are using the SanaCoach heart failure during the study period.	Device: SanaCoach Heart failure; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the SanaCoach heart failure	• Score on the System Usability Scale (SUS)	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	% of users who rate SanaCoach heart failure as "easy to use"; % of users who rate SanaCoach heart failure as "transmits information as intended"; % of users who report satisfaction with the content of information received via SanaCoach heart failure; % of users motivated/intending to use SanaCoach heart failure; % of alerts/messages transmitted via the app that are rated "appropriate" by patient; % of alerts/messages transmitted via the app that are responded to appropriately by patient	Baseline to 6 months
Feasibility of the SanaCoach heart failure	Total number of hours of initial training on the use of SanaCoach heart failure attended by staff, patients, cardiologist; Total number of hours of refresher training on the use of SanaCoach heart failure attended by staff, patients, cardiologists; Total number of minutes/hours for patient counselling over study duration; Total number of minutes/hours spent on health record-keeping over study duration	Baseline to 6 months
Acceptability	• Rate of completion of the intervention (i.e. number of participants who access and complete all aspects of the intervention including lifestyle coach support	Baseline to 6 months
Adherence rates	• Number of completed/uncompleted education and monitoring sessions	Baseline to 6 months
Technology readiness index (TRI)	Technology readiness index (TRI)	Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Number of unscheduled visits due to HF during the study period.; Number of cardiac rehospitalisation during the study period	Baseline to 6 months
Medication adherence	• Changes in self-reported Medication adherence using the Medication Adherence Report Scale (MARS) from baseline to week 26.	Baseline to 6 months
Quality of life assessment	• Changes in the Quality of life assessment with Kansas City Cardiomyopathy Questionnaire (KCCQ-12) from baseline to weeks 12 and 26.	Baseline to 6 months
Well-Being Index	• World Health Organisation- Five Well-Being Index (WHO-5) from baseline to weeks 12 and 26.	Baseline to 6 months
Self-care Behaviour	• Changes on the 9-Item European Heart Failure Self-care Behaviour Scale (EHFScB-9) from baseline to week 26.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: University College Dublin; RWTH Aachen University; Queen's University, Belfast
• Investigators: Principal Investigator: Hans-Peter Brunner-La Rocca, Prof, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: patient education; web application; chronic heart failure; patient self-management
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NL75892.068.20; NWE702 (Other Grant/Funding Number: Interreg NWE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared upon receipt of substantiated request to coordinator of the consortium.
• IPD Sharing Time Frame: After completion of the study. Expected Q2 of 2022
• IPD Sharing Access Criteria: Substantiated request to coordinator of the consortium with details about reason for request , which data and how the data will be used.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No