Heart FailureTEACHNCT07317882
Telematic Educational Intervention in Patients With Heart Failure.
A study testing Digital health in people with Heart Failure and Heart Failure Patients, run by Maria Jose Santi Cano at 1 site in Spain.
Trial summary
Background: Heart Failure (HF) is one of the most prevalent pathologies in Western countries, representing a significant percentage of their healthcare expenditure. Much of the success of specialised programmes for the control and treatment of this pathology is achieved within Heart Failure Units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure Patients
- What is being tested?
- Digital health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2025to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults over 18 years of age.
- Clinical diagnosis of heart failure class II, III and IV.
- Ejection fraction less than or equal to 35%.
- Those who have a smartphone that allows video calls.
Who cannot join
- Patients with impaired cognitive ability, meaning they cannot follow basic self-care and education guidelines.
- Patients with acute heart failure that can be resolved by treating the underlying cause.
- Patients with high comorbidity, where non-cardiac conditions pose a greater risk and have a worse prognosis than heart failure itself.
- Patients enrolled in any other clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Telematic Educational Intervention in Improving Self-care Levels in Patients With Heart Failure
Background: Heart Failure (HF) is one of the most prevalent pathologies in Western countries, representing a significant percentage of their healthcare expenditure. Much of the success of specialised programmes for the control and treatment of this pathology is achieved within Heart Failure Units. These programmes are based on enhancing patients' capacity to perform effective self-care. Self-care in heart failure involves several aspects: maintaining healthy lifestyle habits, monitoring signs and symptoms of decompensation, controlling blood pressure, heart rate, and body weight, and the ability to manage potential decompensations either autonomously or by seeking available healthcare services.
Heart failure units carry out structured therapeutic education for these patients through individualized, face-to-face educational interventions upon admission to the unit, placing special emphasis on training patients and their caregivers in effective self-care. However, studies show that the level of self-care among HF patients remains low. Furthermore, the new healthcare reality following the pandemic situation necessitates the search for strategies that facilitate better time management while improving the self-care capacity of HF patients. Within this clinical context, it is necessary to seek alternatives that allow for the provision of adequate quality of care while overcoming the obstacles imposed by the current situation.
Read more
Objective: The objective of the study is to evaluate the effectiveness of a telematics-based educational intervention, in addition to the standard standardised educational intervention, in self-care in patients in the Heart Failure Unit six months after admission.
Methodology: A randomised clinical trial design with parallel groups (intervention and control) will be applied. The study sample, consisting of 50 patients in each group, will be recruited from patients treated in the Heart Failure Unit of the University Hospital. All patients and their caregivers (if applicable) in both groups will receive the same individualised educational intervention. The patients assigned to the intervention group will also receive a telematics-based educational intervention through video call through the WhatsApp messaging application three months after the initial face-to-face intervention.
The study variables will include sociodemographic and physiological data, adherence to pharmacological treatment, immunisations, dietary assessment, physical exercise assessment, number and management of decompensations, self-care levels and quality of life. After six months in the heart failure unit, all patients in both groups will be reassessed using the same instruments and the statistical differences between the groups will be analysed. The primary outcome variable will be the level of self-care, measured by the European Heart Failure Self-care Behaviour Scale.
- Conditions
- Heart Failure, Heart Failure Patients
- Being tested
- Digital health
- Keywords
- Heart failure, digital health, self care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital healthBehavioural
Education through mHealth
| Study group | Role | What they receive |
|---|---|---|
| Digital health | Experimental | Not described Receives: Behavioral: Digital health |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Heart Failure Self-Care Behaviour Scale
It consists of a 12-item self-administered questionnaire that addresses different aspects of patient self-care. It is scored using a Likert scale from 1 (strongly agree/always) to 5 (strongly disagree/never). This allows for the classification of the overall self-care level within the following ranges: low (44-60), medium (28-43), and high (12-27).
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start7 Jan 2025
- Primary completion7 Mar 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Jose Santi Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Jose Santi Cano, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317882
- Sponsor's protocol ID
- PI-25-07-2024
- Acronym
- TEACH
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telematic Educational Intervention in Improving Self-care Levels in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07317882
- Acronym / sponsor ID
- TEACH / PI-25-07-2024
- Conditions
- Heart Failure, Heart Failure Patients
- Keywords
- Heart failure, digital health, self care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maria Jose Santi CanoUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Mar 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
Background: Heart Failure (HF) is one of the most prevalent pathologies in Western countries, representing a significant percentage of their healthcare expenditure. Much of the success of specialised programmes for the control and treatment of this pathology is achieved within Heart Failure Units. These programmes are based on enhancing patients' capacity to perform effective self-care. Self-care in heart failure involves several aspects: maintaining healthy lifestyle habits, monitoring signs and symptoms of decompensation, controlling blood pressure, heart rate, and body weight, and the ability to manage potential decompensations either autonomously or by seeking available healthcare services.
Heart failure units carry out structured therapeutic education for these patients through individualized, face-to-face educational interventions upon admission to the unit, placing special emphasis on training patients and their caregivers in effective self-care. However, studies show that the level of self-care among HF patients remains low. Furthermore, the new healthcare reality following the pandemic situation necessitates the search for strategies that facilitate better time management while improving the self-care capacity of HF patients. Within this clinical context, it is necessary to seek alternatives that allow for the provision of adequate quality of care while overcoming the obstacles imposed by the current situation.
Objective: The objective of the study is to evaluate the effectiveness of a telematics-based educational intervention, in addition to the standard standardised educational intervention, in self-care in patients in the Heart Failure Unit six months after admission.
Methodology: A randomised clinical trial design with parallel groups (intervention and control) will be applied. The study sample, consisting of 50 patients in each group, will be recruited from patients treated in the Heart Failure Unit of the University Hospital. All patients and their caregivers (if applicable) in both groups will receive the same individualised educational intervention. The patients assigned to the intervention group will also receive a telematics-based educational intervention through video call through the WhatsApp messaging application three months after the initial face-to-face intervention.
The study variables will include sociodemographic and physiological data, adherence to pharmacological treatment, immunisations, dietary assessment, physical exercise assessment, number and management of decompensations, self-care levels and quality of life. After six months in the heart failure unit, all patients in both groups will be reassessed using the same instruments and the statistical differences between the groups will be analysed. The primary outcome variable will be the level of self-care, measured by the European Heart Failure Self-care Behaviour Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital health | Experimental | Behavioral: Digital health |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 18 years of age.
- Clinical diagnosis of heart failure class II, III and IV.
- Ejection fraction less than or equal to 35%.
- Those who have a smartphone that allows video calls.
Key exclusion criteria (4 listed)
- Patients with impaired cognitive ability, meaning they cannot follow basic self-care and education guidelines.
- Patients with acute heart failure that can be resolved by treating the underlying cause.
- Patients with high comorbidity, where non-cardiac conditions pose a greater risk and have a worse prognosis than heart failure itself.
- Patients enrolled in any other clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital healthEducation through mHealth | Behavioural | Digital health |
Primary outcome
European Heart Failure Self-Care Behaviour Scale
Time frame: From enrollment to the end of intervention at 6 months
It consists of a 12-item self-administered questionnaire that addresses different aspects of patient self-care. It is scored using a Likert scale from 1 (strongly agree/always) to 5 (strongly disagree/never). This allows for the classification of the overall self-care level within the following ranges: low (44-60), medium (28-43), and high (12-27).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes
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RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
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?
A study testing Digital health in people with Heart Failure and Heart Failure Patients, run by Maria Jose Santi Cano 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 4 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
European Heart Failure Self-Care Behaviour Scale (time frame: From enrollment to the end of intervention at 6 months). 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 8 Jan 2026.