Coronary Artery DiseaseNCT03268291
Communicational Program "Trust" to Improve Adherence to Medications
A study testing Standard outpatient observation and Communicational program "Trust" in people with Coronary Artery Disease and Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The trial was designed in such a way as to show that the proposed program "Trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Cardiovascular Diseases
- What is being tested?
- Standard outpatient observation and Communicational program "Trust"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2017to 30 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Recent acute myocardial infarction within the past 2 months
- Successful revascularization via coronary stenting or thrombolysis
Who cannot join
- Concomitant cardiovascular disorders requiring surgical treatment
- Coronary revascularization via CABG
- Patient refused from participating
- Patient is not available for communication within 2 months
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
Evgeny Kretov, MD, PhD, sibvolna2005@yandex.ru
Evgeny Kretov, MD, PhD
About this study
Official title: Impact of Communicational Program "Trust" on Adherence to Medications in Patients With Prior Myocardial Infarction Who Underwent Successful Revascularization by Stenting or Thrombolysis: A Prospective Multicenter Randomized Trial
The trial was designed in such a way as to show that the proposed program "Trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.
Read the detailed description
The "Trust" program includes a set of measures aimed at increasing the level of adherence to therapy in patients with myocardial infarction. Differences in adherence rates between patients enrolled in the program and patients undergoing standard outpatient care will be monitored during the study. The study will be conducted according to the clinical approbation protocol, the principles of good clinical practice (GCP) and regulatory requirements.
The developed program is based on the experience of international research studies and includes the following sections:
- daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
- service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
- questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
Information motivating to remain adherence to the therapy is structured as follows:
- greeting and presentation, a reminder of the necessity for therapy, with the support of the patient's Trust in prolonging the quality of life by regular use of medications; B) the explanation of the action of the medicine taking into account the peculiarities of ordinary consciousness, warning the patient of the most common mistakes in treatment; C) recommendations for changing lifestyle and explaining their need; D) a reminder of the possibility to contact the attending physician, emotional support and counseling.
The establishment of an information and counseling center will allow the patient to be supported throughout the time when the likelihood of giving up therapy and the risk of complications due to failure are most likely.
- Being tested
- Standard outpatient observation, Communicational program "Trust"
- Keywords
- Adherence to therapy, Myocardial Infarction, Coronary Artery Disease, Communicational program
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard outpatient observationOther
Outpatient management according to Ministry of health standards
Communicational program "Trust"Behavioural
The developed program is based on the experience of international research studies and includes the following sections:
daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
| Study group | Role | What they receive |
|---|---|---|
| Standard outpatient observation | Active comparator | Outpatient management according to Ministry of health standards Receives: Other: Standard outpatient observation |
| Communicational program "Trust" | Experimental | The developed program is based on the experience of international research studies and includes the following sections:
* daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
* service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
* questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services. Receives: Behavioral: Communicational program "Trust" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Adherence to every class of prescribed medications: Acetylsalicylic acid, P2Y12 receptor inhibitors, Beta-blockers, ACE inhibitors according to percent of medication taking days. Adherence above 80% will be satisfactory
Measured: During 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Mar 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will include 2,000 patients. Patients will be randomized into two groups: standard outpatient observation (n = 1 000), the "Trust" program (n = 1 000).
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268291
- Sponsor's protocol ID
- Call of Trust
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Communicational Program "Trust" on Adherence to Medications in Patients With Prior Myocardial Infarction Who Underwent Successful Revascularization by Stenting or Thrombolysis: A Prospective Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT03268291
- Acronym / sponsor ID
- Call of Trust
- Keywords
- Adherence to therapy, Myocardial Infarction, Coronary Artery Disease, Communicational program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 Aug 2017 (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.
The trial was designed in such a way as to show that the proposed program "Trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.
Detailed description
The "Trust" program includes a set of measures aimed at increasing the level of adherence to therapy in patients with myocardial infarction. Differences in adherence rates between patients enrolled in the program and patients undergoing standard outpatient care will be monitored during the study. The study will be conducted according to the clinical approbation protocol, the principles of good clinical practice (GCP) and regulatory requirements.
The developed program is based on the experience of international research studies and includes the following sections:
- daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
- service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
- questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
Information motivating to remain adherence to the therapy is structured as follows:
- greeting and presentation, a reminder of the necessity for therapy, with the support of the patient's Trust in prolonging the quality of life by regular use of medications; B) the explanation of the action of the medicine taking into account the peculiarities of ordinary consciousness, warning the patient of the most common mistakes in treatment; C) recommendations for changing lifestyle and explaining their need; D) a reminder of the possibility to contact the attending physician, emotional support and counseling.
The establishment of an information and counseling center will allow the patient to be supported throughout the time when the likelihood of giving up therapy and the risk of complications due to failure are most likely.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include 2,000 patients. Patients will be randomized into two groups: standard outpatient observation (n = 1 000), the "Trust" program (n = 1 000).
| Arm | Type | Receives |
|---|---|---|
| Standard outpatient observation | Active comparator | Other: Standard outpatient observationOutpatient management according to Ministry of health standards |
| Communicational program "Trust" | Experimental | Behavioral: Communicational program "Trust"The developed program is based on the experience of international research studies and includes the following sections: * daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; * service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; * questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Recent acute myocardial infarction within the past 2 months
- Successful revascularization via coronary stenting or thrombolysis
Key exclusion criteria (4 listed)
- Concomitant cardiovascular disorders requiring surgical treatment
- Coronary revascularization via CABG
- Patient refused from participating
- Patient is not available for communication within 2 months
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 |
|---|---|---|
| Standard outpatient observationOutpatient management according to Ministry of health standards | Other | Standard outpatient observation |
| Communicational program "Trust"The developed program is based on the experience of international research studies and includes the following sections: daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services. | Behavioural | Communicational program "Trust" |
Primary outcome
Medication Adherence
Time frame: During 1 year
Adherence to every class of prescribed medications: Acetylsalicylic acid, P2Y12 receptor inhibitors, Beta-blockers, ACE inhibitors according to percent of medication taking days. Adherence above 80% will be satisfactory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: Yes. All the data
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard outpatient observation and Communicational program "Trust" in people with Coronary Artery Disease and Myocardial Infarction, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 3 inclusion and 4 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 31 Aug 2017. 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 Russia. 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?
Contact Aleksei Prokhorikhin (9137178040, turbogold@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: During 1 year). 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 31 Aug 2017.