Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.
- Sponsor
- Universidad Miguel Hernandez de Elche
- Study ID
- NCT06510946
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Cardiovascular Diseases
- Chronic Disease
- Coronary Disease
- Secondary Prevention
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease — BEHAVIORALThe intervention involves a comprehensive health education program based on the Chronic Care Model to increase therapeutic adherence in patients with secondary prevention for cardiovascular disease. The program includes the following components: Health Education Sessions: Education on the importance of adherence, understanding the disease, side effects of medications, and their management. It addresses personal beliefs and concerns. Mobile Phone Reminders: Use of alarms and the ti.care® app to remind patients to take their medications. Medication Verification: Ensuring that the medications and dosages taken match the prescriptions. Personalized Dosing Systems (PDS): Helping manage medication intake. Additional Health Advice: Control of other cardiovascular risk factors and benefits of the Mediterranean diet.
Study Details
The goal of this open label randomized controlled trial is to evaluate the efficacy of an intervention through health education based on the Chronic Care Model's implementation to increase therapeutic adherence in patients with secondary prevention for cardiovascular disease. The main questions it aims to answer are: * Null hypothesis (H0): In patients in cardiovascular secondary prevention, an intervention based on the application of the Chronic Care Model does not improve therapeutic adherence to the 3 preventive drugs: Angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins. * Alternative hypothesis (H1): In patients in cardiovascular secondary prevention, an intervention based on the application of the Chronic Care Model improves therapeutic adherence to the 3 preventive drugs: Angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins. Researchers will compare intervention group (health education, use of mobile phones, personalized dosage system) to the control group (routine follow-up).
Key Dates
- First listed
- Jul 19, 2024
- Start date
- Jan 31, 2025
- Status verified
- Jul 2024
- Primary completion
- Dec 31, 2025
- Completion
- Jan 31, 2026
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Intervention groupIntervention group: health education, use of mobile phones, personalized dosage system.
- No Intervention: Control groupRoutine follow-up.
Primary Outcome Measure
Therapeutic adherence [ Time Frame: Through study completion, an average of 1 year. ]
Central Contacts
- Francisco Manuel Lidón Muñoz, Doctor+34 965918550
- Domingo Luis Orozco Beltrán, Professor
Related Studies
- Diabetes and Heart Disease Risk in BlacksRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- Cardiovascular BiorepositoryEnrolling By Invitation · Kenneth S. Campbell · Lexington, Kentucky
- TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
- Evaluating New Radiation Techniques for Cardiovascular ImagingRecruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland