Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.

NCT06510946 | Not Yet Recruiting

• 1 other identifier: 2024-016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases; Chronic Disease; Secondary Prevention; Coronary Disease

Keywords

Treatment Adherence and Compliance; Primary Health Care

Outcome Measures

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.

  Through study completion, an average of 1 year.

Secondary Outcomes (7)

• Group

  This variable will be collected prior to the start of the study.

• Age

  This variable will be collected prior to the start of the study.

• Sex

  This variable will be collected prior to the start of the study.

• Race

  This variable will be collected prior to the start of the study.

• Educational level

  This variable will be collected prior to the start of the study.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: health education, use of mobile phones, personalized dosage system.

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

Control group

NO INTERVENTION

Routine follow-up.

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients identified with therapeutic adherence deficiency, defined as Haynes-Sackett test supplemented with Medication Possession Ratio (MPR) \< 80% for any of the 3 drugs in the previous 6 months.

You may not qualify if:

• 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.
• Life expectancy less than one year.
• Patients whose treatment is managed by a caregiver (professional or family member).
• Patients with Barthel Index \<60.
• Institutionalized patients.
• Patients currently participating in similar research studies.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Babel Health Centre

Alicante, 03007, Spain

Location

Related Publications (1)

• Lidon-Munoz FM, Quesada JA, Gil-Guillen VF, Orozco-Beltran D. Efficacy of an intervention to increase therapeutic adherence in patients with secondary prevention for cardiovascular disease: a study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Jan 7;11:1510744. doi: 10.3389/fmed.2024.1510744. eCollection 2024.

  PMID: 39839644 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Chronic Disease; Coronary Disease; Treatment Adherence and Compliance

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Francisco Manuel Lidón Muñoz

  Universidad Miguel Hernández de Elche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Manuel Lidón Muñoz, Doctor

CONTACT

+34 965918550; francisco.lidon@goumh.umh.es

Domingo Luis Orozco Beltrán, Professor

CONTACT

dorozco@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's in Medicine. PhD student.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 19, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)