Adherence, MedicationADHERENCENCT03766789
Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.
A study testing Cell phone application in people with Adherence, Medication, run by Instituto Cardiovascular de Buenos Aires at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adherence, Medication
- What is being tested?
- Cell phone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteArgentina
- Study dates
- 12 Jun 2018to 27 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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). -
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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.
- Conditions
- Adherence, Medication
- Being tested
- Cell phone application
- Keywords
- Adherence, Medication, Therapy
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell phone applicationDevice
cell phone to organize medications
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | They will receive the cell phone application, as reminder of medications time and dose. Receives: Device: Cell phone application |
| Control | No intervention | Patients will receive standard of care recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start12 Jun 2018
- Primary completion27 Nov 2018
- Study completion27 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Cardiovascular de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Costabel, Instituto Cardiovascular de Buenos Aires
- Investigators
- Juan P Costabel, MD, Principal investigator, Chief of coronary care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766789
- Sponsor's protocol ID
- A0001
- Acronym
- ADHERENCE
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03766789
- Acronym / sponsor ID
- ADHERENCE / A0001
- Conditions
- Adherence, Medication
- Keywords
- Adherence, Medication, Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Cardiovascular de Buenos AiresUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Jan 2019 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Cell phone applicationThey will receive the cell phone application, as reminder of medications time and dose. |
| Control | No intervention | –Patients will receive standard of care recommendations. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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). -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell phone applicationcell phone to organize medications | Device | Intervention |
Primary outcome
Adherence to treatment
Time frame: 3 months
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)
1 secondary outcome
Impact in clinical events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan P Costabel, MD principal investigator
Chief of coronary care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell phone application in people with Adherence, Medication, run by Instituto Cardiovascular de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.