Clinical trial NCT03766789: Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherence, Medication
Keywords: Adherence, Medication, Therapy
Lead sponsor: Instituto Cardiovascular de Buenos Aires
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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). -

Primary outcomes:
measure: Adherence to treatment
timeFrame: 3 months
Secondary outcomes:
measure: Impact in clinical events
timeFrame: 3 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Juan Pablo Costabel
Study officials:
affiliation: Chief of coronary care unit
name: Juan P Costabel, MD
role: PRINCIPAL_INVESTIGATOR
References: