Cardiovascular DiseaseNCT00713960
CARE - Quality Improvement in Cardiovascular Secondary Prevention in Primary Care, Through Delegation of Consultations to the Nurse.
An observational study of Cardiovascular Disease, run by AstraZeneca at 66 sites in Denmark.
Trial summary
Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 2,193 participants
- Where
- 66 sitesDenmark
- Study dates
- Apr 2008to Dec 2010
- 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: Primary care clinic
Who may be able to join
- Patients in secondary prevention of cardiopathy (ischaemic heart disease, claudication intermittence, thrombotic apoplexy cerebri, diabetes) who are not followed in an outpatient department.
Who cannot join
- Patients who suffer from diabetic nephropathy will be excluded
- According to the general practitioners appraisal, patients who suffer from severe co morbidity can be excluded as well.
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
Denmark66 sites
Research Site
Albertslund
Research Site
Arhus C
Research site
Assens
Research Site
Billund
Research Site
Brabrand
Research Site
Elsinore
Research Site
Erslev
Research Site
Esbjerg
Research Site
Faaborg
Research Site
Gentofte Municipality
Research Site
Give
Research Site
Greve
Research Site
Hadsund
Research Site
Hedehusene
Research Site
Hillerød
Research Site
Hinnerup
Research Site
Hjallerup
Research Site
Hjørring
Research Site
Hobro
Research Site
Holaek
Research Site
Holstebro
Research Site
Hørning
Research Site
Hornsyld
Research Site
Horsens
Research Site
Karup
Research Site
Kbh. O
Research Site
Kerteminde
Research Site
Kjellerup
Research Site
Klarup
Research Site
København Ø
Research site
Kobenhavn V
Research Site
Køge
Research Site
Kolding
Research Site
Kolding C
Research Site
Kongens Lyngby
Research Site
Lemvig
Research Site
Lystrup
Research Site
Maribo
Research Site
Næstved
Research Site
Nivå
Research Site
Odense C
Research Site
Pandrup
Research Site
Randers
Research Site
Ringsted
Research Site
Rødding
Research Site
Roskilde
Research Site
Rungsted Kyst
Research Site
Silkeborg
Research Site
Skælskør
Research Site
Solrød Strand
Research Site
Sønder Felding
Research Site
Sønderborg
Research Site
Stege
Research Site
Struer Municipality
Research Site
Svendborg
Research Site
Svinninge
Research Site
Thisted
Research Site
Tune
Research Site
Vamdrup
Research Site
Varde
Research Site
Vejen Municipality
Research Site
Vejle
Research Site
Vestervig
Research Site
Viborg
Research Site
Viby J
Research Site
Vivild
About this study
Official title: CARE - Quality Development in Cardiovascular Disease in General Practice
Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice
- Conditions
- Cardiovascular Disease
- Keywords
- Quality development project, primary care nurses, cardiovascular disease, secondary prevention, follow-up
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients in secondary prevention of cardiovascular disease in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol, HDL -cholesterol, LDL-Cholesterol, Blood pressure, Exercise, Waist-circumference, BMI, Smoking status, fasting plasma-glucose, medication taken
Measured: As needed, min. baseline and after 6 months
Secondary outcomes (1)
Number of visits pr. patients, drop-out
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 2,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Ommen, MD, Study chair, Lægerne i Løgumkloster I/S, DenmarkDorte Knudsen, Study chair, Lægerne Sønderåparken, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713960
- Sponsor's protocol ID
- NIS-CDK-DUM-2008/1
- Status last verified
- Jan 2012
- First submitted
- 10 Jul 2008
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE - Quality Development in Cardiovascular Disease in General Practice
- ClinicalTrials.gov ID
- NCT00713960
- Acronym / sponsor ID
- NIS-CDK-DUM-2008/1
- Conditions
- Cardiovascular Disease
- Keywords
- Quality development project, primary care nurses, cardiovascular disease, secondary prevention, follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,193 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Jul 2008 (estimated)
- 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.
Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients in secondary prevention of cardiovascular disease in primary care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Patients in secondary prevention of cardiopathy (ischaemic heart disease, claudication intermittence, thrombotic apoplexy cerebri, diabetes) who are not followed in an outpatient department.
Key exclusion criteria (2 listed)
- Patients who suffer from diabetic nephropathy will be excluded
- According to the general practitioners appraisal, patients who suffer from severe co morbidity can be excluded as well.
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
Cholesterol, HDL -cholesterol, LDL-Cholesterol, Blood pressure, Exercise, Waist-circumference, BMI, Smoking status, fasting plasma-glucose, medication taken
Time frame: As needed, min. baseline and after 6 months
1 secondary outcome
Number of visits pr. patients, drop-out
Time frame: Annually
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 16 Jan 2012.
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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.
Henrik Ommen, MD study chair
Lægerne i Løgumkloster I/S, Denmark
Dorte Knudsen study chair
Lægerne Sønderåparken, Denmark
66 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by AstraZeneca at 66 sites in Denmark.
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 2 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 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Denmark. 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?
Cholesterol, HDL -cholesterol, LDL-Cholesterol, Blood pressure, Exercise, Waist-circumference, BMI, Smoking status, fasting plasma-glucose, medication taken (time frame: As needed, min. baseline and after 6 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 16 Jan 2012.