Atrial FibrillationAFClinicNCT00753259
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.
A study testing AF Clinic and Care as Usual in people with Atrial Fibrillation, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Randomized controlled trial comparing specialized AF Clinic with 'care as usual' Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AF Clinic and Care as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2006to Jan 2010
- 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
- Newly diagnosed atrial fibrillation
Who cannot join
- Age < 18 years
- unwillingness to participate
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Martini Hospital Groningen
Groningen, 9700 RM
MaastrichtUMC
Maastricht, 6202 AZ
About this study
Official title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
- Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
- Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.
- Conditions
- Atrial Fibrillation
- Being tested
- AF Clinic, Care as Usual
- Keywords
- atrial fibrillation, disease management program, integrated chronic care program, guideline, stroke, heart failure, quality of life, costs
- Medical subject headings
- Atrial Fibrillation, Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ClinicOther
Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment
Care as UsualOther
Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.
| Study group | Role | What they receive |
|---|---|---|
| AF Clinic | Experimental | Not described Receives: Other: AF Clinic |
| Care as Usual | Active comparator | Not described Receives: Other: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.
Measured: minimum of 1 year
Secondary outcomes (1)
All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness.
Measured: minimum of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert G Tieleman, MD PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753259
- Sponsor's protocol ID
- MEC 06-4-043
- Acronym
- AFClinic
- Status last verified
- Apr 2010
- First submitted
- 15 Sep 2008
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hendriks JM, Vrijhoef HJ, Crijns HJ, Brunner-La Rocca HP. The effect of a nurse-led integrated chronic care approach on quality of life in patients with atrial fibrillation. Europace. 2014 Apr;16(4):491-9. doi: 10.1093/europace/eut286. Epub 2013 Sep 20.
PubMed 24058179Hendriks JM, Crijns HJ, Tieleman RG, Vrijhoef HJ. The atrial fibrillation knowledge scale: development, validation and results. Int J Cardiol. 2013 Sep 30;168(2):1422-8. doi: 10.1016/j.ijcard.2012.12.047. Epub 2013 Jan 8.
PubMed 23305860Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.
PubMed 22453654Hendriks JM, de Wit R, Vrijhoef HJ, Tieleman RG, Crijns HJ. An integrated chronic care program for patients with atrial fibrillation: study protocol and methodology for an ongoing prospective randomised controlled trial. Int J Nurs Stud. 2010 Oct;47(10):1310-6. doi: 10.1016/j.ijnurstu.2009.12.017. Epub 2010 Jan 20.
PubMed 20089253
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT00753259
- Acronym / sponsor ID
- AFClinic / MEC 06-4-043
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, disease management program, integrated chronic care program, guideline, stroke, heart failure, quality of life, costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Sep 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.
- Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
- Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF Clinic | Experimental | Other: AF Clinic |
| Care as Usual | Active comparator | Other: Care as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed atrial fibrillation
Key exclusion criteria (2 listed)
- Age < 18 years
- unwillingness to participate
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 |
|---|---|---|
| AF ClinicTreatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment | Other | AF Clinic |
| Care as UsualRoutine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software. | Other | Care as Usual |
Primary outcome
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.
Time frame: minimum of 1 year
1 secondary outcome
All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness.
Time frame: minimum of 1 year
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 20 Apr 2010.
- Derived from this study: PubMed 24058179Hendriks JM, Vrijhoef HJ, Crijns HJ, Brunner-La Rocca HP. The effect of a nurse-led integrated chronic care approach on quality of life in patients with atrial fibrillation. Europace. 2014 Apr;16(4):491-9. doi: 10.1093/europace/eut286. Epub 2013 Sep 20.
- Derived from this study: PubMed 23305860Hendriks JM, Crijns HJ, Tieleman RG, Vrijhoef HJ. The atrial fibrillation knowledge scale: development, validation and results. Int J Cardiol. 2013 Sep 30;168(2):1422-8. doi: 10.1016/j.ijcard.2012.12.047. Epub 2013 Jan 8.
- Derived from this study: PubMed 22453654Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.
- Derived from this study: PubMed 20089253Hendriks JM, de Wit R, Vrijhoef HJ, Tieleman RG, Crijns HJ. An integrated chronic care program for patients with atrial fibrillation: study protocol and methodology for an ongoing prospective randomised controlled trial. Int J Nurs Stud. 2010 Oct;47(10):1310-6. doi: 10.1016/j.ijnurstu.2009.12.017. Epub 2010 Jan 20.
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Atrial Fibrillation (AF)
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.
Robert G Tieleman, MD PhD principal investigator
Maastricht UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF Clinic and Care as Usual in people with Atrial Fibrillation, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (time frame: minimum of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00753259, which also lists 4 linked publications.
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 20 Apr 2010.