|- candidate number||21039|
|- NTR Number||NTR4914|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-nov-2014|
|- Secondary IDs||ZonMw 839110006 MERC number 2014_236|
|- Public Title||Detecting and Diagnosing Atrial Fibrillation|
|- Scientific Title||Detecting and Diagnosing Atrial Fibrillation: enhanced case-finding in high risk patients from general practice and evaluating three ways of irregular pulse detection. A cluster randomised trial with nested diagnostic studies.
|- hypothesis||With optimized case finding more patients with atrial fibrillation (AF) will be detected than with usual care. We expect this is cost-effective, because expensive adverse events resulting from AF can be prevented with generally cheap interventions. |
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation|
|- Inclusion criteria||1. Age of 65 years or older |
2. No previously documented AF
|- Exclusion criteria||1. Having a pacemaker.|
2. Legal incompetence or unable to give informed consent.
3. Suffering from terminal illness.
4. Unable to come to the practice to participate in the diagnostic process, for instance a patient who is chronically bedridden. Patients who cannot visit the practice due to a temporary situation (such as the flu) are not excluded.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-sep-2015|
|- planned closingdate||1-jan-2018|
|- Target number of participants||19200|
|- Interventions||Randomization occurs at practice level.
In the intervention practices, we perform optimized case finding. Marked patients who visit the practice are offered three index tests: pulse palpation, electronic sphygmomanometer with AF-detection (‘eBPM-AF’) and handheld one-lead electrocardiogram (‘hand-ECG’). The reference standard is the conventional 12-lead ECG. In case of a negative reading, two week Holter recording is performed to detect paroxysmal AF. Patients taking home the Holter device, also perform measurements with a hand-ECG at home, three times a day. |
Control practices perform usual care.
|- Primary outcome||(1) The difference between intervention and control practices in the number of patients with newly found AF during one year.|
(2) Sensitivity, specificity and other diagnostic parameters of pulse palpation, eBPM-AF and hand-ECG, respectively, using the 12-lead ECG and/or 2 week Holter monitoring as reference standard.
|- Secondary outcome||- Diagnostic test characteristics of the hand-ECG for home monitoring using the two week Holter monitoring as reference standard.|
- The number of patients with all index tests negative (a regular pulse with palpation and with eBPM-AF and hand-ECG not showing AF) in whom the Holter shows (paroxysmal) AF.
- Description of the ‘usual care’ in the diagnostic work-up for AF (process evaluation of control practices), disclosing divergence from current guidelines.
- Prevalence and incidence of (paroxysmal) AF in general practices in the Dutch general practice.
- Diagnostic informativeness of patient profiles of newly detected patients with AF, including patient profiles of newly detected patients with ‘silent’ paroxysmal AF.
- Comparison of the prevalence and incidence of AF between patients of Caucasian and non-Caucasian origin.
- The cost effectiveness of optimized case finding (overall, and for each of the index tests separately) compared to usual care. The outcome of the analysis will be incremental costs per life year gained and per quality adjusted life year gained.
- Prediction model for finding (different types of) AF.
|- Timepoints||1: History of the patiënt, office measurements, if indicated 12-lead ECG. Time frame: 1 day. |
2: If indicated 2-week Holter. Time frame: 2 weeks.
3: Questionnaire on quality of life. Time frame: 1 year.
|- Trial web site||www.d2af.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| N. Verbiest - van Gurp|
|- CONTACT for SCIENTIFIC QUERIES|| H.E.J.H. Stoffers|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Academic Medical Center (AMC), Amsterdam, Microlife, Retomed|
|- Publications||Verbiest - van Gurp N. Vroege diagnose van atriumfibrilleren. Huisarts en wetenschap. 2014;57(10):540
Uittenbogaart SB. Asymptomatisch atriumfibrilleren opsporen. Huisarts en wetenschap. 2014;57(12):653
|- Brief summary||Atrial fibrillation (AF) is the cause of stroke in 15 to 29 percent of the cases. Treatment of AF with anticoagulants reduces the risk of stroke with 60%. The prevalence of atrial fibrillation is high and increases with age.|
AF is a good candidate for case-finding because it is a treatable risk factor for stroke and it often presents asymptomatic, especially among elderly.
In a cluster randomized trial in primary care, we compare enhanced case-finding with usual care. In the interventention arm, we conduct a cross sectional diagnostic study to compare three methods of AF-detection: pulse palpation, sphygmomanometer with AF-detection and single lead electrocardiogram (ECG), using 12 lead ECG and/or two-week Holter monitoring as reference standard.
We recruit 96 clusters of 200 patients from one general practice. Patients are 65 years old or over.
Primary endpoints of the study are the difference in detection of newly found AF during one year and the diagnostic test characteristics of the three index tests.
|- Main changes (audit trail)|
|- RECORD||25-nov-2014 - 14-feb-2016|