Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.

Sponsor
Universidad Miguel Hernandez de Elche
Study ID
NCT06510946
Status
Not Yet Recruiting

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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 — BEHAVIORAL
    The 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 group
    Intervention group: health education, use of mobile phones, personalized dosage system.
  • No Intervention: Control group
    Routine follow-up.

Primary Outcome Measure

Therapeutic adherence [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

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