- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07317882
Telematic Educational Intervention in Patients With Heart Failure. (TEACH)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cádiz
-
Cadiz, Cádiz, Spain, 11009
- University Hospital of Jerez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Digital health
|
Education through mHealth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From enrollment to the end of intervention at 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI-25-07-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Indiana UniversityRecruitingCongestive Heart Failure | Congestive Heart Failure (CHF) | Congestive Heart Failure Chronic | Congestive Heart Failure(CHF)United States
-
University of Health Sciences LahoreRecruitingAcute Decompensated Heart Failure | Heart Failure, Diastolic | Heart Failure, SystolicPakistan
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Lakeland Regional Health Systems, Inc.RecruitingHeart Failure | Heart Failure Acute | Acute Heart Failure (AHF) | Heart Failure - NYHA II - IVUnited States
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Eli Lilly and CompanyNot yet recruitingHeart Failure | Heart Failure, Diastolic | Heart Failure, SystolicUnited States, Japan
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
Clinical Trials on Digital health
-
Pack HealthGlaxoSmithKline; University of WashingtonRecruitingMultiple Myeloma | Relapsed Hematologic MalignancyUnited States
-
National University of MalaysiaNot yet recruitingResilience | Depression - Major Depressive DisorderMalaysia
-
Icahn School of Medicine at Mount SinaiNoom Inc.Completed
-
University of Alabama at BirminghamAmerican Heart Association; ConnectionHealth; Memora HealthRecruitingPregnancy Complications | Infant Conditions | Maternal Distress | Adverse Birth OutcomesUnited States
-
Yi YangNot yet recruitingHead and Neck Vascular StenosisChina
-
University of TorontoAssociation for Social Development, Pakistan; Canadian Institutes of Health...RecruitingCOVID-19 | Noncommunicable DiseasesPakistan
-
Pack HealthNovartis; Ohio State University Comprehensive Cancer CenterTerminatedLymphoma, Large B-Cell, DiffuseUnited States
-
Arba Minch UniversityNot yet recruitingTuberculosis, Pulmonary
-
Deutsches Herzzentrum MuenchenTechnical University of Munich; Stiftung KinderHerz Deutschland gGmbHRecruitingPediatric ALL | Congenital Heart DiseaseGermany
-
Deutsches Herzzentrum MuenchenInstitute of Preventive Pediatrics, Technical University of Munich; Stiftung...CompletedCongenital Heart DiseaseGermany