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)

• ClinicalTrials.gov Identifier: NCT04699253
• Recruitment Status: Recruiting
• First Posted: January 7, 2021
• Last Update Posted: September 30, 2022
• Sponsor: Maastricht University Medical Center
• Collaborators: RWTH Aachen University; Queen's University, Belfast; University College Dublin
• Information provided by (Responsible Party): Maastricht University Medical Center

Tracking Information

• First Submitted Date: December 16, 2020
• First Posted Date: January 7, 2021
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 6, 2021)

Usability of the SanaCoach heart failure [ Time Frame: Baseline to 6 months ]

• Score on the System Usability Scale (SUS)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 6, 2021)

• Usability [ Time Frame: Baseline to 6 months ]
  • % 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
• Feasibility of the SanaCoach heart failure [ Time Frame: Baseline to 6 months ]
  • 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
• Acceptability [ Time Frame: Baseline to 6 months ]
  • Rate of completion of the intervention (i.e. number of participants who access and complete all aspects of the intervention including lifestyle coach support
• Adherence rates [ Time Frame: Baseline to 6 months ]
  • Number of completed/uncompleted education and monitoring sessions
• Technology readiness index (TRI) [ Time Frame: Baseline to 6 months ]
  Technology readiness index (TRI)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 6, 2021)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

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

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Ambulatory heart failure patients evaluated in 4 different European sites
• Condition: Chronic Heart Failure

Intervention

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.

Study Groups/Cohorts

• Consenting participants
  Patients meeting the eligibility criteria and are using the SanaCoach heart failure during the study period.
  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 6, 2021): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hesam Amin, MD; +31433877097; hesam.amin@mumc.nl

• Listed Location Countries: Germany, Ireland, Netherlands, United Kingdom

Administrative Information

• NCT Number: NCT04699253
• Other Study ID Numbers: NL75892.068.20; NWE702 ( Other Grant/Funding Number: Interreg NWE )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data will be shared upon receipt of substantiated request to coordinator of the consortium.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (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.

• Current Responsible Party: Maastricht University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Maastricht University Medical Center
• Original Study Sponsor: Same as current

Collaborators

• RWTH Aachen University
• Queen's University, Belfast
• University College Dublin

Investigators

• Principal Investigator: Hans-Peter Brunner-La Rocca, Prof; Maastricht University Medical Center

• PRS Account: Maastricht University Medical Center
• Verification Date: January 2022