Clinical trial NCT04699253: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
patient self-management
patient education
web application
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
name: Queen's University, Belfast
name: University College Dublin
First posted: 2021-01-07
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory heart failure patients evaluated in 4 different 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.

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.

Primary outcomes:
measure: Usability of the SanaCoach heart failure
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Usability
timeFrame: Baseline to 6 months
measure: Feasibility of the SanaCoach heart failure
timeFrame: Baseline to 6 months
measure: Acceptability
timeFrame: Baseline to 6 months
measure: Adherence rates
timeFrame: Baseline to 6 months
measure: Technology readiness index (TRI)
timeFrame: Baseline to 6 months
Other outcomes:
measure: Effectiveness
timeFrame: Baseline to 6 months
measure: Medication adherence
timeFrame: Baseline to 6 months
measure: Quality of life assessment
timeFrame: Baseline to 6 months
measure: Well-Being Index
timeFrame: Baseline to 6 months
measure: Self-care Behaviour
timeFrame: Baseline to 6 months
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Dublin
country: Ireland
facility: St. Michael's Hospital Dublin
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital Belfast
city: Ipswich
country: United Kingdom
facility: University of Suffolk
Study officials:
affiliation: Maastricht University Medical Center
name: Hans-Peter Brunner-La Rocca, Prof
role: PRINCIPAL_INVESTIGATOR
References: