Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NWE702 | Other Grant/Funding Number | Interreg NWE |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| RWTH Aachen University | OTHER |
| Queen's University, Belfast | OTHER |
| University College Dublin | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consenting participants | Patients meeting the eligibility criteria and are using the SanaCoach heart failure during the study period. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the SanaCoach heart failure | • Score on the System Usability Scale (SUS) | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness |
| Baseline to 6 months |
| Medication adherence | • Changes in self-reported Medication adherence using the Medication Adherence Report Scale (MARS) from baseline to week 26. |
Inclusion Criteria:
Patients must meet ALL of the following criteria in order to be eligible for this study.
Exclusion Criteria:
Patients meeting any of the following criteria are NOT eligible for this study
Not provided
Not provided
Not provided
Ambulatory heart failure patients evaluated in 4 different European sites
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans-Peter Brunner-La Rocca, Prof | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Aachen | Aachen | Germany | ||||
| St. Michael's Hospital Dublin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40110213 | Derived | 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. |
Not provided
Not provided
Individual participant data will be shared upon receipt of substantiated request to coordinator of the consortium.
After completion of the study. Expected Q2 of 2022
Substantiated request to coordinator of the consortium with details about reason for request , which data and how the data will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline to 6 months |
| Feasibility of the SanaCoach heart failure |
| 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 |
| 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 |
| Dublin |
| Ireland |
| Maastricht UMC+ | Maastricht | Netherlands |
| Royal Victoria Hospital Belfast | Belfast | United Kingdom |
| University of Suffolk | Ipswich | United Kingdom |