Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome. (ADHERENCE)
Primary Purpose
Adherence, Medication
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Cell phone application
Sponsored by
About this trial
This is an interventional supportive care trial for Adherence, Medication focused on measuring Adherence, Medication, Therapy
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). -
Sites / Locations
- Juan Pablo Costabel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
They will receive the cell phone application, as reminder of medications time and dose.
Patients will receive standard of care recommendations.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03766789
First Posted
December 2, 2018
Last Updated
December 14, 2018
Sponsor
Instituto Cardiovascular de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT03766789
Brief Title
Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
January 27, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Cardiovascular de Buenos Aires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Medication
Keywords
Adherence, Medication, Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
They will receive the cell phone application, as reminder of medications time and dose.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive standard of care recommendations.
Intervention Type
Device
Intervention Name(s)
Cell phone application
Intervention Description
cell phone to organize medications
Primary Outcome Measure Information:
Title
Adherence to treatment
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Impact in clinical events
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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). -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan P Costabel, MD
Organizational Affiliation
Chief of coronary care unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Pablo Costabel
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.
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