Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure

NCT06869408 | Completed

• 1 other identifier: CAP-IC
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Caaring; DTx; real-world data; Digital Health; Remote patient monitoring

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (7)

• Change in the use of health resources

  Day 0 and Mothly up to 3 months

• Changes in the patient's quality of life scale: WHOQOL

  Day 0, week 4 and week 12]

• Changes in the patient's MEDAS scale: Adherence to Mediterranean Diet

  Day 0, week 4 and week 12

• Changes in the patient's in EHFScB: European Heart Failure Self-Care Behaviour Scale

  Day 0, week 4 and week 12

• Changes in the patient's in Liquid Consumption

  Day 0, week 4 and week 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (1)

Hospital Universitario Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: February 24, 2025
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)