Type II DiabetesSTADIANCT04499846
Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients
An observational study of Type II Diabetes, run by Lille Catholic University at 1 site in France.
Trial summary
The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Therapeutic education
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2020to 7 May 2021
- 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: Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or Saint-Vincent hospitals (Lille, France)
Who may be able to join
- 18 years old or more
- Type 2 diabetes
- Following treatment with statins
- Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent Hospitals (Lille, France).
- Ability to answer the Girerd test in both interviews (in the individual interview and by phone)
- Patient informed to participate in the study
- Signed patient's consent.
Who cannot join
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients
The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.
- Conditions
- Type II Diabetes
- Being tested
- Therapeutic education
- Keywords
- Diabetes, Compliance, Statin, Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Patients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients following education | Patients will followed an educational intervention about physiopathology of diabetes and mechanisms of action of statins. A questionnaire will allow to measure compliance to the treatment. Receives: Other: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate to the statin treatment
Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
Measured: 3 months
Secondary outcomes (2)
Compliance rate to the statin treatment according to schedule of drug intake
Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
Measured: 3 months
Compliance rate to the statin treatment according to treatment duration.
Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient.
For the interpretation of the test:
Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
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 posted5 Aug 2020
- Study start11 Jun 2020
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Delecourt, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499846
- Sponsor's protocol ID
- RC-P0096
- Other IDs
- 2020-A00402-37
- Acronym
- STADIA
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2020
- Last updated
- 13 Oct 2021
- 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 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients
- ClinicalTrials.gov ID
- NCT04499846
- Acronym / sponsor ID
- STADIA / RC-P0096
- Conditions
- Type II Diabetes
- Keywords
- Diabetes, Compliance, Statin, Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 5 Aug 2020 (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 objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients following education | – | Other: Therapeutic educationPatients will followed an educational intervention about physiopathology of diabetes and mechanisms of action of statins. A questionnaire will allow to measure compliance to the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or Saint-Vincent hospitals (Lille, France)
Key inclusion criteria (7 listed)
- 18 years old or more
- Type 2 diabetes
- Following treatment with statins
- Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent Hospitals (Lille, France).
- Ability to answer the Girerd test in both interviews (in the individual interview and by phone)
Key exclusion criteria (1 listed)
- Patients under guardianship
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 |
|---|---|---|
| Therapeutic educationPatients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance. | Other | Diabetic patients following education |
Primary outcome
Compliance rate to the statin treatment
Time frame: 3 months
Compliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient. For the interpretation of the test: Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as "poor compliance".
2 secondary outcomes
Compliance rate to the statin treatment according to schedule of drug intake
Time frame: 3 months
Compliance rate to the statin treatment according to treatment duration.
Time frame: 3 months
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 13 Oct 2021.
- 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.
François Delecourt, MD principal investigator
GHICL
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 Type II Diabetes, run by Lille Catholic University at 1 site in France.
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 7 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 13 Oct 2021. 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 France. 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?
Compliance rate to the statin 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 13 Oct 2021.