Clinical trial NCT06869408: Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure
Official title: Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Keywords: Heart Failure
Caaring
DTx
real-world data
Digital Health
Remote patient monitoring
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2025-03-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Informed Consent is obtained from the patient
* Patients diagnosed with heart failure with reduced ejection fraction (EF≤40%)
* Patients who extensively use a smartphone.

Exclusion Criteria:

* Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
* Patients with inability to give adequately the informed consent.

Primary outcomes:
measure: Patients' ability to report data through a digital platform: Clinical situation
timeFrame: Day 0, every 3 days up to week 12
measure: Patients' ability to report data through a digital platform: Treatment and adherence
timeFrame: Day 0, and weekly up to week 12
measure: Patients' ability to report data through a digital platform: Quality of Life
timeFrame: Day 0, Week 4 and Week 12
measure: Patients' ability to report data through a digital platform: Mediterranean Diet Adherence
timeFrame: Day 0, Week 4 and Week 12
measure: Patients' ability to report data through a digital platform: European Heart Failure Self-Care Behaviour Scale
timeFrame: Day 0, Week 4 and Week 12
measure: Patients' ability to report data through a digital platform: Liquid Consumption Questionnaire
timeFrame: Day 0, Week 4 and Week 12
measure: Patient participation rate
timeFrame: Week 12
measure: Percentage of patients with at least 80% of data completed.
timeFrame: Week 12
measure: Percentage of patients with 100% of data completed.
timeFrame: Week 12
Secondary outcomes:
measure: Change in the use of health resources
timeFrame: Day 0 and Mothly up to 3 months
measure: Changes in the patient's quality of life scale: WHOQOL
timeFrame: Day 0, week 4 and week 12]
measure: Changes in the patient's MEDAS scale: Adherence to Mediterranean Diet
timeFrame: Day 0, week 4 and week 12
measure: Changes in the patient's in EHFScB: European Heart Failure Self-Care Behaviour Scale
timeFrame: Day 0, week 4 and week 12
measure: Changes in the patient's in Liquid Consumption
timeFrame: Day 0, week 4 and week 12
measure: Changes in the patient's: Adherence to treatment
timeFrame: Day 0, Weekly up to Week 12
measure: Changes in the patient's Clinical Data
timeFrame: Day 0, every 3 days up to Week 12
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Llatzer
state: Islas Baleares
Study officials:
References: