Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510946
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Improving Therapeutic Adherence in Cardiovascular Secondary Prevention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of an Intervention to Increase Therapeutic Adherence in Patients With Secondary Prevention for Cardiovascular Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AT-PSC
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 Models 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 inhibitorsAngiotensin 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 inhibitorsAngiotensin 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
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 inhibitorsAngiotensin 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 inhibitorsAngiotensin 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 worldwides 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 Models 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
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 Models 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None