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Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.

NCT06510946 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-19

No results posted yet for this study

Summary

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).

Conditions

Interventions

BEHAVIORAL

(Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease

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.

Sponsors & Collaborators

  • Universidad Miguel Hernandez de Elche

    lead OTHER

Principal Investigators

  • Francisco Manuel Lidón Muñoz · Universidad Miguel Hernández de Elche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510946 on ClinicalTrials.gov