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OpenTrials
Completed

NCT Number: NCT06869408

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patients' ability to report data through a digital platform: Clinical situation

    Time frame: Day 0, every 3 days up to week 12

    Percentage of patients with at least 80% of the data completed per form: clinical situation.

  2. Patients' ability to report data through a digital platform: Treatment and adherence

    Time frame: Day 0, and weekly up to week 12

    Percentage of patients with at least 80% of the data completed per form: treatment and adherence.

  3. Patients' ability to report data through a digital platform: Quality of Life

    Time frame: Day 0, Week 4 and Week 12

    Percentage of patients with at least 80% of the data completed of the quality life questionnaire WHOQOL (World Health Organization Quality Of Life)

  4. Patients' ability to report data through a digital platform: Mediterranean Diet Adherence

    Time frame: Day 0, Week 4 and Week 12

    Percentage of patients with at least 80% of the data completed by MEDAS (Mediterranean Diet Adherence Screener) questionnaire

  5. Patients' ability to report data through a digital platform: European Heart Failure Self-Care Behaviour Scale

    Time frame: Day 0, Week 4 and Week 12

    Percentage of patients with at least 80% of the data completed by EHFScB (European Heart Failure Self-Care Behaviour Scale) scale

  6. Patients' ability to report data through a digital platform: Liquid Consumption Questionnaire

    Time frame: Day 0, Week 4 and Week 12

    Percentage of patients with at least 80% of the data completed by Liquid Consumption Questionnaire

  7. Patient participation rate

    Time frame: Week 12

    Patient participation rate defined as the ratio between the questionnaries requested and completed

  8. Percentage of patients with at least 80% of data completed.

    Time frame: Week 12

    Percentage of patients with at least 80% of data completed in the application

  9. Percentage of patients with 100% of data completed.

    Time frame: Week 12

    Percentage of patients with 100% of data completed in the application.

Secondary outcomes

  1. Change in the use of health resources

    Time frame: Day 0 and Mothly up to 3 months

    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.

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

    Time frame: Day 0, week 4 and week 12]

    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.

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

    Time frame: Day 0, week 4 and week 12

    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.

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

    Time frame: Day 0, week 4 and week 12

    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.

  5. Changes in the patient's in Liquid Consumption

    Time frame: Day 0, week 4 and week 12

    Changes in patient's Liquid Consumption Questionnaire. The changes will be measured through a specific form created for this purpose

  6. Changes in the patient's: Adherence to treatment

    Time frame: Day 0, Weekly up to Week 12

    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

  7. Changes in the patient's Clinical Data

    Time frame: Day 0, every 3 days up to Week 12

    Changes in patient's Clinical data (symptoms related to heart failure) measured through a specific form created for this purpose.

Sponsors and collaborators

Lead sponsor

Persei Vivarium

Other

Collaborators

  • Effice Servicios Para la Investigacion S.L.

Registry information

Acronym: CAP-IC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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