Atrial FibrillationNCT01928121
Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
A study testing Care provided by AF expert program in people with Atrial Fibrillation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices. 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?
- Care provided by AF expert program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Aug 2016
- 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
- Every newly diagnosed AF patient.
- Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
- AF must be confirmed on electrocardiogram.
- Capable of providing written informed consent.
- Dutch speaking and verbally testable, without cognitive impairment.
Who cannot join
- AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
- AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
- Terminally ill AF patients
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Leuven
Leuven, Vlaams Brabant, 3000
Dana Berti, 0032-16-341848, dana.berti@uzleuven.be
Hein Heidbuchel, 0032-16-344248, hein.heidbuchel@uzleuven.be
About this study
Official title: Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.
- Conditions
- Atrial Fibrillation
- Being tested
- Care provided by AF expert program
- Keywords
- nurse, expert program, primary care, implementation, interdisciplinary, effectiveness, disease management system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care provided by AF expert programOther
| Study group | Role | What they receive |
|---|---|---|
| AF expert program | Experimental | Care provided by the interdisciplinary, nurse-coordinated AF expert program Receives: Other: Care provided by AF expert program |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular events
Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits.
- Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac
- Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs
- Unplanned cardiovascular visits
Measured: after 1 year
Secondary outcomes (8)
Guideline adherence
- Does the medical record report a formal CHA2DS2-VASc score, HAS-BLED bleeding risk score and EHRA score?
- Does the medical record report an appropriate prescription of antithrombotic treatment.
- Does the medical record report an appropriate application of rate and rhythm (not if asymptomatic, if contraindicated and not in patients with permanent AF)
- Does the medical record report an appropriate upstream therapy? (For example in heart failure patients, is the heart failure treated)
Measured: after 1 year
Hospitalization days and clinic visits
- Number of outpatient (internal or neurological) clinic visits per year
- Number of emergency room visits per year due to AF
- Number of hospitalization days due to AF
- Number of hospitalization days for cardiovascular reasons
- Number of hospitalization days on intensive care due to AF
Measured: after 1 year
Perceived health
Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
Measured: After 1 year
AF related symptoms and symptom burden
AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
Measured: After 1 year
Patient satisfaction
Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
Measured: After year
Patient knowledge
The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
Measured: After 1 year
Patient adherence with medication
This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).
Measured: After 1 year
Time to establishment of a management plan by electrophysiologist or cardiologist
This outcome will be searched for by reviewing medical records of, or by interviewing, all participating patients at 1, 3, 6 months and 1 year.
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Heidbuchel, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928121
- Sponsor's protocol ID
- not yet applicable
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01928121
- Acronym / sponsor ID
- not yet applicable
- Conditions
- Atrial Fibrillation
- Keywords
- nurse, expert program, primary care, implementation, interdisciplinary, effectiveness, disease management system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 23 Aug 2013 (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.
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF expert program | Experimental | Other: Care provided by AF expert programCare provided by the interdisciplinary, nurse-coordinated AF expert program |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Every newly diagnosed AF patient.
- Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
- AF must be confirmed on electrocardiogram.
- Capable of providing written informed consent.
- Dutch speaking and verbally testable, without cognitive impairment.
Key exclusion criteria (4 listed)
- AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
- AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
- Terminally ill AF patients
- Participation in another clinical trial
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 |
|---|---|---|
| Care provided by AF expert program | Other | AF expert program |
Primary outcome
cardiovascular events
Time frame: after 1 year
Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits. * Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac * Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs * Unplanned cardiovascular visits
8 secondary outcomes
Guideline adherence
Time frame: after 1 year
Hospitalization days and clinic visits
Time frame: after 1 year
Perceived health
Time frame: After 1 year
AF related symptoms and symptom burden
Time frame: After 1 year
Patient satisfaction
Time frame: After year
Patient knowledge
Time frame: After 1 year
Patient adherence with medication
Time frame: After 1 year
Time to establishment of a management plan by electrophysiologist or cardiologist
Time frame: After 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care provided by AF expert program in people with Atrial Fibrillation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Berti (0032-479-845016, dana.berti@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular events (time frame: after 1 year). 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 26 Aug 2013.