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.
ID
Bron
Verkorte titel
Aandoening
Atrial fibrillation
Ondersteuning
Academic Medical Center (AMC) Amsterdam
AMC
Microlife
Retomed
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
(1) The difference between intervention and control practices in the number of patients with newly found AF during one year.<br>
(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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
N. Verbiest - van Gurp
Maastricht
The Netherlands
043 388 2947
nicole.vangurp@maastrichtuniversity.nl
Wetenschappelijk
N. Verbiest - van Gurp
Maastricht
The Netherlands
043 388 2947
nicole.vangurp@maastrichtuniversity.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age of 65 years or older
2. No previously documented AF
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4776 |
NTR-old | NTR4914 |
Ander register | MERC number 2014_236 : ZonMw 839110006 |
Samenvatting resultaten
<br><br>
Uittenbogaart SB. Asymptomatisch atriumfibrilleren opsporen. Huisarts en wetenschap. 2014;57(12):653