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
Study Type
OBSERVATIONAL
Enrollment
6
Hospital Universitario Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0, Week 4 and Week 12
Patient participation rate
Patient participation rate defined as the ratio between the questionnaries requested and completed
Time frame: 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
Time frame: Week 12
Percentage of patients with 100% of data completed.
Percentage of patients with 100% of data completed in the application.
Time frame: Week 12
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.
Time frame: Day 0 and Mothly up to 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Day 0, every 3 days up to Week 12