Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.

Adherence, Medication Clinical Trial

— ADHERENCE  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766789
• Other study ID #: A0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: January 27, 2019

Study information

• Verified date: December 2018
• Source: Instituto Cardiovascular de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: January 27, 2019
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years of age.

• Acquire hospitalization for acute coronary syndromes (ACS) with and without ST segment elevation.

• Have access to a smartphone in order to access the digital application provided.

• Have the possibility to follow up after 90 days.

• Sign the informed consent administered in writing prior to inclusion in the clinical trial.

Exclusion Criteria:

• Patients with coronary lesions with a revascularization planned (revascularization in stages).

• Severe limitation of mobility (amputation, degenerative myopathies, musculoskeletal disorders).

• Total or intermediate dependency for carrying out tasks of daily life according to the validated Katz questionnaire of Activities of Daily Life (ADL). -

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Adherence, Medication

Intervention

Device:
• Cell phone application
cell phone to organize medications

Locations

Country	Name	City	State
Argentina	Juan Pablo Costabel	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Cardiovascular de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to treatment	Rate of patients in each arm with adherence to medical treatment defined by the Morisky Green scale.; The eight-item Morisky Medication Adherence Scale (MMAS-8) is a structured self-report measure of medication-taking behavior that has been widely used in various cultures. The first seven items are dichotomous response categories with yes or no and the last item was a five point Likert response. The adherence to medications is higher in patients with higher scale values (values from 0 to 8). A patient is consider to have good adherence when score is perfect (8 points)	3 months
Secondary	Impact in clinical events	Rate of patients in each arm with the combined event of re-hospitalizations for acute coronary syndromes, consultations to the medical emergency system or not planned visits to clinic.	3 months