Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03766789
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-02
Brief Title:
Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome
Sponsor:
Instituto Cardiovascular de Buenos Aires
Organization:
Instituto Cardiovascular de Buenos Aires
Study Overview
Official Title:
Use of a Smartphone Digital Application as a Tool to Increase Adherence to Medical Treatment in Patients Who Underwent Hospitalization for Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADHERENCE
Brief Summary:
ADHERENCE is a randomized unicentric study that will be carried out from a monovalent center of cardiology of the Autonomous City of Buenos Aires Patients will be randomized hospitalization for acute coronary syndromes ACS with and without ST segment elevation at the time of hospital discharge to receive access to a digital application for smartphones or receive written instructions regarding the taking of medication as prescribed by doctors They will have a total follow-up period of 90 days in which the adherence to medical treatment will be evaluated through a questionnaire validated for that purpose
The objective of the study is to demonstrate that the use of a digital platform for smartphones increases the adherence to medical treatment by 30 in relation to the group without intervention
The objective of the study is to demonstrate that the use of a digital platform for smartphones increases the adherence to medical treatment by 30 in relation to the group without intervention
Detailed Description:
The World Health Organization WHO states that poor adherence to long-term medical treatments severely compromises their effectiveness with an expected adherence of 50 in developed countries and less in developing countries This non-compliance to medical treatment tends to increase as the global burden of chronic diseases increases where not only the rational use of medicines but also compliance with prescribed treatments becomes vitally important So it is of interest to highlight the importance not only of the clarity of the medical prescription at the time of hospital discharge but of compliance with it in the out-of-hospital setting
The lack of adherence to medical treatment is a difficult problem to solve and this could partially explain the ineffectiveness of the treatments administered by the health system Adherence is greater in the acute phase of the disease2 presenting a marked decrease within 3 to 6 months of treatment3 In order to avoid this problem multiple interventions have been studied without evidence of significant benefits or clinical impact
The Medication Reminder application will be used as a digital tool for smartphones which is available for different commercial software platforms free download The intervention group will have the installation of the aforementioned platform on your smartphone loading the list of your medication as well as an alarm in the hours proposed for the shot When the warning is presented the patient will have a warning by which he will have to accept or reject the taking of the medication to reject it the reminder will remain present for 24hs and then it will be automatically deleted At the end of the day the patient can access an analysis of daily compliance and thus perform a self-monitoring The control group will receive the standard of care consisted of a written list of medications
We will evaluate the adherence to medications at 3 months as primary endpoint
The lack of adherence to medical treatment is a difficult problem to solve and this could partially explain the ineffectiveness of the treatments administered by the health system Adherence is greater in the acute phase of the disease2 presenting a marked decrease within 3 to 6 months of treatment3 In order to avoid this problem multiple interventions have been studied without evidence of significant benefits or clinical impact
The Medication Reminder application will be used as a digital tool for smartphones which is available for different commercial software platforms free download The intervention group will have the installation of the aforementioned platform on your smartphone loading the list of your medication as well as an alarm in the hours proposed for the shot When the warning is presented the patient will have a warning by which he will have to accept or reject the taking of the medication to reject it the reminder will remain present for 24hs and then it will be automatically deleted At the end of the day the patient can access an analysis of daily compliance and thus perform a self-monitoring The control group will receive the standard of care consisted of a written list of medications
We will evaluate the adherence to medications at 3 months as primary endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None