Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.
NCT Number: NCT06510946
Acronym: AT-PSC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases|Chronic Disease|Secondary Prevention|Coronary Disease
Interventions: BEHAVIORAL: (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease
Sponsor: Universidad Miguel Hernandez de Elche
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01
Completion Date: 2026-01
Locations: Babel Health Centre, Alicante, 03007, Spain

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).

Primary Outcome Measures: 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., Through study completion, an average of 1 year.
Secondary Outcome Measures: Group, Intervention group and control group, This variable will be collected prior to the start of the study.|Age, Years old, This variable will be collected prior to the start of the study.|Sex, Man and woman, This variable will be collected prior to the start of the study.|Race, Caucasian Black Asian Hispanic Other, This variable will be collected prior to the start of the study.|Educational level, Illiterate. Primary education (Elementary school or Compulsory Secondary Education). Vocational training and vocational education. High school diploma (Baccalaureate). Higher education: bachelor's degree, master's degree, and/or doctorate., This variable will be collected prior to the start of the study.|The Barthel index, The main aim is to establish degree of independence., This variable will be collected prior to the start of the study.|Quality of life studied using the European Quality of Life-5 Dimensions, The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement., This variable will be collected prior to the start of the study.