Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Heart Failure has a global prevalence of 1 to 3% in the adult population with an incidence of 1 to 20 cases per 1,000 people. Furthermore, HF is often associated with a number of comorbidities (anaemia, arrhythmias, depression, hyperuricemia, coronary heart disease etc.), which greatly deteriorates the patient's quality of life.
Despite the development of specific drugs, HF has a very high mortality rate, and it is the first cause of unscheduled income. An increase of 50% of these incomes is expected in the next 25 years.
In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
This study focuses on studying the ability of heart failure patients with reduced ejection fraction (EF≤40%) to use a digital platform through an application installed on the patient's smartphone.
This is an observational, prospective, single-center study. The protocol and informed consent document have been reviewed and approved by the Ethical Committee and the study will be performed in accordance with the Declaration of Helsinki
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Patients' ability to report data through a digital platform: Clinical situation | Percentage of patients with at least 80% of the data completed per form: clinical situation. | Day 0, every 3 days up to week 12 |
| Patients' ability to report data through a digital platform: Treatment and adherence | Percentage of patients with at least 80% of the data completed per form: treatment and adherence. | Day 0, and weekly up to week 12 |
| Patients' ability to report data through a digital platform: Quality of Life | Percentage of patients with at least 80% of the data completed of the quality life questionnaire WHOQOL (World Health Organization Quality Of Life) | Day 0, Week 4 and Week 12 |
| Patients' ability to report data through a digital platform: Mediterranean Diet Adherence | Percentage of patients with at least 80% of the data completed by MEDAS (Mediterranean Diet Adherence Screener) questionnaire | Day 0, Week 4 and Week 12 |
| Patients' ability to report data through a digital platform: European Heart Failure Self-Care Behaviour Scale | Percentage of patients with at least 80% of the data completed by EHFScB (European Heart Failure Self-Care Behaviour Scale) scale | Day 0, Week 4 and Week 12 |
| Patients' ability to report data through a digital platform: Liquid Consumption Questionnaire | Percentage of patients with at least 80% of the data completed by Liquid Consumption Questionnaire | Day 0, Week 4 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the use of health resources | Change in patient´s use of health resources scores at basal monthly and at the end of the study compared to baseline: Number of visits to specialists (e.g. cardiology, primary care, etc.), number of emergency room visits, or number of hospital readmissions. The changes will be measured through a specific form created for this purpose. | Day 0 and Mothly up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with heart failure with reduced ejection fraction (EF≤40%)from Hospital Universitario Son Llatzer who met the inclusion criteria and sign the informed consent will be included.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Patient participation rate | Patient participation rate defined as the ratio between the questionnaries requested and completed | Week 12 |
| Percentage of patients with at least 80% of data completed. | Percentage of patients with at least 80% of data completed in the application | Week 12 |
| Percentage of patients with 100% of data completed. | Percentage of patients with 100% of data completed in the application. | Week 12 |
| Changes in the patient's quality of life scale: WHOQOL | Changes in patient's quality of life scale WHOQOL (World Health Organization Quality of Life) scores at week 4 and at the end of the study compared to baseline. Values: 0-100, a higher score reflects a better health-related quality of life. | Day 0, week 4 and week 12] |
| Changes in the patient's MEDAS scale: Adherence to Mediterranean Diet | Changes in patient's scale MEDAS (Mediterranean Diet Adherence Screener) scores at week 4 and at the end of the study compared to baseline. Values: 0-14, a higher score reflects a better the adherence to the Mediterranean Diet. | Day 0, week 4 and week 12 |
| Changes in the patient's in EHFScB: European Heart Failure Self-Care Behaviour Scale | Changes in patient's EHFScB scale (European Heart Failure Self-Care Behaviour scale) scores at week 4 and at the end of the study compared to baseline. Values: 0-100, a higher score reflects a better Self-Care Behaviour in the standardized score. | Day 0, week 4 and week 12 |
| Changes in the patient's in Liquid Consumption | Changes in patient's Liquid Consumption Questionnaire. The changes will be measured through a specific form created for this purpose | Day 0, week 4 and week 12 |
| Changes in the patient's: Adherence to treatment | Changes in patient's Adherence to treatment measured by patient self-report. The questionnaire ask for treatments taken or forgotten. Changes will be measured through a specific form created for this purpose | Day 0, Weekly up to Week 12 |
| Changes in the patient's Clinical Data | Changes in patient's Clinical data (symptoms related to heart failure) measured through a specific form created for this purpose. | Day 0, every 3 days up to Week 12 |