Cardiovascular DiseasesNCT07040800
Adherence to Pharmacotherapy in Patients Admitted for Inpatient Treatment at the Scientific Medical Center (PRIMULA)
An observational study of Cardiovascular Diseases, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
This cross-sectional observational study will assess adherence to previously prescribed medication in patients admitted to inpatient treatment at the scientific medical center. When filling out the questionnaire, the previously prescribed pharmacotherapy, the regularity of medication intake and the presence of side… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,463 participants
- Where
- 1 siteRussia
- Study dates
- 19 Feb 2025to 27 Feb 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: patients admitted to a multidisciplinary hospital
Who may be able to join
- all patients admitted to the scientific center, signed patients' informed consent
Who cannot join
- patient's unsigned informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Centre for Therapy and Preventive Medicine
Moscow, 109380
About this study
Official title: Adherence to Pharmacotherapy in Patients Admitted for Inpatient Treatment at the Scientific Medical Center
This cross-sectional observational study will assess adherence to previously prescribed medication in patients admitted to inpatient treatment at the scientific medical center. When filling out the questionnaire, the previously prescribed pharmacotherapy, the regularity of medication intake and the presence of side effects of drug treatment, if any, according to their medical history will be clarified.
- Conditions
- Cardiovascular Diseases
- Keywords
- drug therapy, medical recommendations, commitment
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with NSEPh adherence score ≥3 (i.e., complete secondary or complete primary non-commitment) at baseline
Commitment to treatment was determined using the National Society of Evidence-Based Pharmacotherapy (NSEPh) adherence scale.
Based on the scores obtained, patients are categorized as follows:
- 0 points - full adherence
- 1 point - partial (incomplete) non-commitment, unintentional violations
- 2 points - partial (incomplete) non-commitment, intentional violations (including self-medication)
- 3 points - complete secondary non-commitment
- 4 points - complete primary non-commitment The threshold for defining non-adherence was set at ≥3 points.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start19 Feb 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,463 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040800
- Sponsor's protocol ID
- 01-06/25
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Pharmacotherapy in Patients Admitted for Inpatient Treatment at the Scientific Medical Center
- ClinicalTrials.gov ID
- NCT07040800
- Acronym / sponsor ID
- 01-06/25
- Conditions
- Cardiovascular Diseases
- Keywords
- drug therapy, medical recommendations, commitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,463 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 27 Jun 2025 (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.
This cross-sectional observational study will assess adherence to previously prescribed medication in patients admitted to inpatient treatment at the scientific medical center. When filling out the questionnaire, the previously prescribed pharmacotherapy, the regularity of medication intake and the presence of side effects of drug treatment, if any, according to their medical history will be clarified.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to a multidisciplinary hospital
Key inclusion criteria (1 listed)
- all patients admitted to the scientific center, signed patients' informed consent
Key exclusion criteria (1 listed)
- patient's unsigned informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with NSEPh adherence score ≥3 (i.e., complete secondary or complete primary non-commitment) at baseline
Time frame: Baseline
Commitment to treatment was determined using the National Society of Evidence-Based Pharmacotherapy (NSEPh) adherence scale. Based on the scores obtained, patients are categorized as follows: * 0 points - full adherence * 1 point - partial (incomplete) non-commitment, unintentional violations * 2 points - partial (incomplete) non-commitment, intentional violations (including self-medication) * 3 points - complete secondary non-commitment * 4 points - complete primary non-commitment The threshold for defining non-adherence was set at ≥3 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by National Medical Research Center for Therapy and Preventive Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with NSEPh adherence score ≥3 (i.e., complete secondary or complete primary non-commitment) at baseline (time frame: Baseline). 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 11 Sep 2026.