Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Miguel Hernandez de Elche
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of both sexes, aged over 18 years old, who, after reading the patient information sheet, provide written informed consent.
Patients in secondary prevention receiving daily single-dose angiotensin converting enzyme inhibitors/Angiotensin II receptor blockers, acetylsalicylic acid, and statins for 6 months or more.
Diagnosis of any of the following cardiovascular diseases: cerebrovascular disease, ischemic heart disease, or peripheral vascular disease.
Patients under follow-up at our primary care center.
Disqualifiers
Patients who refuse to participate.
Incomplete completion of informed consent.
Language barrier.
Patients diagnosed with psychiatric, psychological, neurological, and/or social problems that hinder intervention or follow-up.
Trial design
Design model
Parallel
Treatments tested in this trial
(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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Therapeutic adherence
Its evaluation will be carried out using the Haynes-Sackett test to determine therapeutic adherence vs. non-adherence (dichotomous qualitative variable) complemented with the Medication Possession Ratio (MPR), estimating a percentage (continuous quantitative variable). Good adherence is considered if the patient reports no difficulties in taking all their pills and has an MPR \> 80% for the 3 preventive drugs. Otherwise, it is considered poor therapeutic adherence. Poor therapeutic adherence is defined by the MPR if 20% or more of the prescribed packages have not been collected from the pharmacy in the last year. Poor adherence is determined if it is diagnosed by either method. As 3 drugs are analyzed, poor therapeutic adherence is considered if it occurs with any one of them, with two, or with all three. To evaluate therapeutic adherence, the Haynes-Sackett test will be administered, complemented by the MPR from the medical records.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Group
Intervention group and control group
Time frame
This variable will be collected prior to the start of the study.2
Age
Years old
Time frame
This variable will be collected prior to the start of the study.3
Sex
Man and woman
Time frame
This variable will be collected prior to the start of the study.4
Race
Caucasian Black Asian Hispanic Other
Time frame
This variable will be collected prior to the start of the study.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: