Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
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|ClinicalTrials.gov Identifier: NCT01928121|
Recruitment Status : Unknown
Verified August 2013 by Prof Heidbuchel, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : August 23, 2013
Last Update Posted : August 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Care provided by AF expert program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: AF expert program
Care provided by the interdisciplinary, nurse-coordinated AF expert program
Other: Care provided by AF expert program
|No Intervention: Usual care|
- 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
- Guideline adherence [ Time Frame: after 1 year ]
- 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)
- Hospitalization days and clinic visits [ Time Frame: after 1 year ]
- 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
- Perceived health [ Time Frame: After 1 year ]Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
- AF related symptoms and symptom burden [ Time Frame: After 1 year ]AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
- Patient satisfaction [ Time Frame: After year ]Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
- Patient knowledge [ Time Frame: After 1 year ]The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
- Patient adherence with medication [ Time Frame: After 1 year ]This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).
- Time to establishment of a management plan by electrophysiologist or cardiologist [ Time Frame: After 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928121
|Contact: Dana Bertiemail@example.com|
|Contact: Hein Heidbuchelfirstname.lastname@example.org|