An observational study in Chronic Heart Failure, sponsored by Maastricht University Medical Center. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Maastricht University Medical Center · Observational
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.
Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ambulatory heart failure patients evaluated in 4 different European sites
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Patients meeting the eligibility criteria and are using the SanaCoach heart failure during the study period.
Device: SanaCoach Heart failure
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.
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.
Usability of the SanaCoach heart failure
• Score on the System Usability Scale (SUS)
Time frame: Baseline to 6 months
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
Time frame: 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
Time frame: 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
Time frame: Baseline to 6 months
Adherence rates
• Number of completed/uncompleted education and monitoring sessions
Time frame: Baseline to 6 months
Technology readiness index (TRI)
Technology readiness index (TRI)
Time frame: Baseline to 6 months
Effectiveness
* Number of unscheduled visits due to HF during the study period. * Number of cardiac rehospitalisation during the study period
Time frame: Baseline to 6 months
Medication adherence
• Changes in self-reported Medication adherence using the Medication Adherence Report Scale (MARS) from baseline to week 26.
Time frame: 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.
Time frame: Baseline to 6 months
Well-Being Index
• World Health Organisation- Five Well-Being Index (WHO-5) from baseline to weeks 12 and 26.
Time frame: 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.
Time frame: Baseline to 6 months
Plan to share: Yes — Individual participant data will be shared upon receipt of substantiated request to coordinator of the consortium.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Ran from Jul 2021 to primary completion in Dec 2023, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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