Cardiovascular DiseasesAT-PSCNCT06510946
Improving Therapeutic Adherence in Cardiovascular Secondary Prevention.
A study testing (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease in people with Cardiovascular Diseases and Chronic Disease, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Chronic Disease, Secondary Prevention
- What is being tested?
- (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Patients with Barthel Index <60.
- Institutionalized patients.
- Patients currently participating in similar research studies.
Trial locations and contacts
1 site in 1 country.
Domingo Luis Orozco Beltrán, Professor contact
Spain1 site
Babel Health Centre
Alicante, 03007
Francisco Manuel Lidón Muñoz, francisco.lidon@goumh.umh.es
Domingo Luis Orozco Beltrán
About this study
Official title: Efficacy of an Intervention to Increase Therapeutic Adherence in Patients With Secondary Prevention for Cardiovascular Disease.
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).
Read the detailed description
Cardiovascular diseases are the worldwide's leading cause of mortality. Within the spectrum of these diseases, cerebrovascular disease, coronary heart disease, and peripheral vascular disease are included. Secondary prevention is an effective strategy in patients with previous events, being the most used drugs antihypertensives, statins and salicylic acetyl acid.
Therapeutic adherence in these patients is crucial, as the lack of it, results in increased morbidity and mortality, as well as decreased quality of life and raised healthcare costs. However, less than half of the patients take all three medications during the first year. In addition, the lack of therapeutic adherence is easier to measure in the primary care setting.
Objective: 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.
Methods: Open label randomized controlled trial, selecting patients presenting the inclusion criteria through consecutive probability sampling. Random assignment will be carried out using a random number table.
Intervention on patients in the experimental group will be conducted through health education following the recommendations of the Chronic Care Model (CCM). The aim is to empower patients to manage their disease through therapeutic education measures and shared decision-making with the patient.
Two individual sessions (one in the first month and another in the fourth month) and four group sessions (one per quarter with 5 to 10 patients) will be conducted. The individual sessions will last 30 minutes, and the group sessions will last 1 hour.
In the first quarter, an individual session will be held in the first month, followed by a group session in the second month. In the second quarter, another individual session will be held in the fourth month, and a group session in the sixth month. Subsequently, group sessions will continue with one scheduled in the ninth month and another in the twelfth month.
Considering a therapeutic adherence of 50% in the control group and an expected therapeutic adherence of 80% in the intervention group, with a type II error of 20% (80% power), a type I error of 5% (95% confidence interval), and a 15% loss rate, a sample size of 45 patients in each group is estimated.
The follow-up period will be conducted for one year. After data collection, a descriptive univariate analysis of the variables and a bivariate analysis will be performed. Finally, a multivariate analysis will be conducted to isolate potential confounding factors and to analyze the impact of the intervention on therapeutic adherence.
- Being tested
- (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease
- Keywords
- Treatment Adherence and Compliance, Primary Health Care
- Medical subject headings
- Cardiovascular Diseases, Chronic Disease, Coronary Disease, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular diseaseBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group: health education, use of mobile phones, personalized dosage system. Receives: Behavioral: (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease |
| Control group | No intervention | Routine follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (7)
Group
Intervention group and control group
Measured: This variable will be collected prior to the start of the study.
Age
Years old
Measured: This variable will be collected prior to the start of the study.
Sex
Man and woman
Measured: This variable will be collected prior to the start of the study.
Race
Caucasian Black Asian Hispanic Other
Measured: 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.
Measured: This variable will be collected prior to the start of the study.
The Barthel index
The main aim is to establish degree of independence.
Measured: 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.
Measured: This variable will be collected prior to the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Manuel Lidón Muñoz, Universidad Miguel Hernandez de Elche
- Investigators
- Francisco Manuel Lidón Muñoz, Principal investigator, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510946
- Sponsor's protocol ID
- 2024-016
- Acronym
- AT-PSC
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39839644
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intervention to Increase Therapeutic Adherence in Patients With Secondary Prevention for Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT06510946
- Acronym / sponsor ID
- AT-PSC / 2024-016
- Keywords
- Treatment Adherence and Compliance, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cardiovascular diseases are the worldwide's leading cause of mortality. Within the spectrum of these diseases, cerebrovascular disease, coronary heart disease, and peripheral vascular disease are included. Secondary prevention is an effective strategy in patients with previous events, being the most used drugs antihypertensives, statins and salicylic acetyl acid.
Therapeutic adherence in these patients is crucial, as the lack of it, results in increased morbidity and mortality, as well as decreased quality of life and raised healthcare costs. However, less than half of the patients take all three medications during the first year. In addition, the lack of therapeutic adherence is easier to measure in the primary care setting.
Objective: 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.
Methods: Open label randomized controlled trial, selecting patients presenting the inclusion criteria through consecutive probability sampling. Random assignment will be carried out using a random number table.
Intervention on patients in the experimental group will be conducted through health education following the recommendations of the Chronic Care Model (CCM). The aim is to empower patients to manage their disease through therapeutic education measures and shared decision-making with the patient.
Two individual sessions (one in the first month and another in the fourth month) and four group sessions (one per quarter with 5 to 10 patients) will be conducted. The individual sessions will last 30 minutes, and the group sessions will last 1 hour.
In the first quarter, an individual session will be held in the first month, followed by a group session in the second month. In the second quarter, another individual session will be held in the fourth month, and a group session in the sixth month. Subsequently, group sessions will continue with one scheduled in the ninth month and another in the twelfth month.
Considering a therapeutic adherence of 50% in the control group and an expected therapeutic adherence of 80% in the intervention group, with a type II error of 20% (80% power), a type I error of 5% (95% confidence interval), and a 15% loss rate, a sample size of 45 patients in each group is estimated.
The follow-up period will be conducted for one year. After data collection, a descriptive univariate analysis of the variables and a bivariate analysis will be performed. Finally, a multivariate analysis will be conducted to isolate potential confounding factors and to analyze the impact of the intervention on therapeutic adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular diseaseIntervention group: health education, use of mobile phones, personalized dosage system. |
| Control group | No intervention | –Routine follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular diseaseThe 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. | Behavioural | Intervention group |
Primary outcome
Therapeutic adherence
Time frame: Through study completion, an average of 1 year.
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.
7 secondary outcomes
Group
Time frame: This variable will be collected prior to the start of the study.
Age
Time frame: This variable will be collected prior to the start of the study.
Sex
Time frame: This variable will be collected prior to the start of the study.
Race
Time frame: This variable will be collected prior to the start of the study.
Educational level
Time frame: This variable will be collected prior to the start of the study.
The Barthel index
Time frame: This variable will be collected prior to the start of the study.
Quality of life studied using the European Quality of Life-5 Dimensions
Time frame: This variable will be collected prior to the start of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 39839644Lidon-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domingo Luis Orozco Beltrán, Professor contact
Francisco Manuel Lidón Muñoz principal investigator
Universidad Miguel Hernández de Elche.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Health education program) To increase therapeutic adherence in patients with secondary prevention for cardiovascular disease in people with Cardiovascular Diseases and Chronic Disease, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Manuel Lidón Muñoz, Doctor (+34 965918550, francisco.lidon@goumh.umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic adherence (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.