AsthmaNCT00714038
CARE - Quality Improvement in Asthma Secondary Prevention in Primary Care, Through Delegation of Consultations to the Nurse.
An observational study of Asthma, run by AstraZeneca at 93 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
- Asthma
- How many people
- 2,122 participants
- Where
- 93 sitesDenmark
- Study dates
- May 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
- diagnosed with asthma
Who cannot join
- patients with copd
Trial locations and contacts
93 sites in 1 country.
93 sites in 1 country
Denmark93 sites
Research Site
Aabenraa
Research Site
Aabybro
Research Site
Aalborg
Research Site
Aarhus
Research Site
Albertslund
Research Site
Arhus C
Research Site
Arhus N
Research Site
Ballerup Municipality
Research Site
Birkerød
Research Site
Brabrand
Research Site
Brønshøj
Research Site
Bryrup
Research Site
Christiansfeld
Research Site
Dybvad
Research Site
Elsinore
Research Site
Erslev
Research Site
Espergorde
Research Site
Fakse
Research Site
Fredericia
Research Site
Frederikshavn
Research Site
Frostruo
Research Site
Gedsted
Research Site
Gram
Research Site
Haderslev
Research Site
Hadsund
Research Site
Hasselager
Research Site
Hedehusene
Research Site
Herfølge
Research Site
Herlev
Research Site
Herning
Research Site
Hinnerup
Research Site
Hjørring
Research Site
Hobro
Research Site
Højer
Research Site
Holbæk
Research Site
Holstebro
Research Site
Holte
Research Site
Hørning
Research Site
Horsens
Research Site
Hørsholm
Research Site
Humlaek
Research Site
Hurup Thy
Research Site
Ikast
Research Site
Jægerspris
Research Site
Karlslunde
Research Site
Karup
Research Site
Kåstrup
Research Site
Kbh. NV
Research Site
Kerteminde
Research Site
Kjellerup
Research Site
København S
Research Site
Køge
Research Site
Kolding
Research Site
Kongens Lyngby
Research Site
Låsby
Research Site
Lemvig
Research Site
Middelfart
Research Site
Møldrup
Research Site
Næstved
Research Site
Nordborg
Research Site
Nyborg
Research Site
Nykøbing Falster
Research Site
Nykobing Sj�lland
Research Site
Odense C
Research Site
Randers
Research Site
Ribe
Research Site
Rødovre Municipality
Research Site
Roskilde
Research Site
Sakskøbing
Research Site
Silkeborg
Research Site
Skive
Research Site
Skørping
Research Site
Skovlunde
Research Site
Slagelse
Research Site
Slangerup
Research Site
Snekkersten
Research Site
Solbjerg
Research Site
Solrod Srand
Research Site
Sønderborg
Research Site
Storvorde
Research Site
Støvring
Research Site
Svendborg
Research Site
Tarm
Research Site
Terndrup
Research Site
Thisted
Research Site
Uldum
Research Site
Vallensaek Strand
Research Site
Vanløse
Research Site
Varde
Research Site
Vejle
Research Site
Viborg
Research Site
Virum
Research Site
Vojens
About this study
Official title: CARE - Quality Development in Asthma in General Practice
Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice
- Conditions
- Asthma
- Keywords
- Quality development project, primary care nurses, asthma, patient compliance, follow-up
- Medical subject headings
- Asthma, Patient Compliance
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 with asthma in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function, improvements in lung function over time, patient compliance with treatment
Measured: baseline, when necessary and at 1 year control
Secondary outcomes (1)
Number of visits per patient, drop-out rate
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 startMay 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 AsthmaStudies 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
- 2,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00714038
- Sponsor's protocol ID
- NIS-RDK-DUM-2008/1
- Status last verified
- Mar 2011
- First submitted
- 10 Jul 2008
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE - Quality Development in Asthma in General Practice
- ClinicalTrials.gov ID
- NCT00714038
- Acronym / sponsor ID
- NIS-RDK-DUM-2008/1
- Conditions
- Asthma
- Keywords
- Quality development project, primary care nurses, asthma, patient compliance, follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,122 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 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 with asthma 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)
- diagnosed with asthma
Key exclusion criteria (1 listed)
- patients with copd
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
Lung function, improvements in lung function over time, patient compliance with treatment
Time frame: baseline, when necessary and at 1 year control
1 secondary outcome
Number of visits per patient, drop-out rate
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 9 Mar 2011.
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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
93 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 93 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 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 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 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?
Lung function, improvements in lung function over time, patient compliance with treatment (time frame: baseline, when necessary and at 1 year control). 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 9 Mar 2011.