Heart FailureCAP-ICNCT06869408
Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure
An observational study of Heart Failure, run by Persei Vivarium at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2025to 25 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
About this study
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.
Read more
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.
Read the 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
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Caaring, DTx, real-world data, Digital Health, Remote patient monitoring
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0, Week 4 and Week 12
Patient participation rate
Patient participation rate defined as the ratio between the questionnaries requested and completed
Measured: 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
Measured: Week 12
Percentage of patients with 100% of data completed.
Percentage of patients with 100% of data completed in the application.
Measured: Week 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 0, every 3 days up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start24 Feb 2025
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Persei Vivarium
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869408
- Sponsor's protocol ID
- CAP-IC
- Acronym
- CAP-IC
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Patient's Ability to Use a Digital Platform in Heart Failure
- ClinicalTrials.gov ID
- NCT06869408
- Acronym / sponsor ID
- CAP-IC / CAP-IC
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Caaring, DTx, real-world data, Digital Health, Remote patient monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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)
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
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
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
Patient participation rate
Time frame: Week 12
Patient participation rate defined as the ratio between the questionnaries requested and completed
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
Percentage of patients with 100% of data completed.
Time frame: Week 12
Percentage of patients with 100% of data completed in the application.
7 secondary outcomes
Change in the use of health resources
Time frame: Day 0 and Mothly up to 3 months
Changes in the patient's quality of life scale: WHOQOL
Time frame: Day 0, week 4 and week 12]
Changes in the patient's MEDAS scale: Adherence to 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
Time frame: Day 0, week 4 and week 12
Changes in the patient's in Liquid Consumption
Time frame: Day 0, week 4 and week 12
Changes in the patient's: Adherence to treatment
Time frame: Day 0, Weekly up to Week 12
Changes in the patient's Clinical Data
Time frame: Day 0, every 3 days up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Persei Vivarium at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' ability to report data through a digital platform: Clinical situation (time frame: Day 0, every 3 days up to week 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.