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Detecting and Diagnosing Atrial Fibrillation: enhanced case-finding in patients from general practice and evaluating three ways of irregular pulse detection. A cluster randomised trial with nested diagnostic studies

Detecting and Diagnosing Atrial Fibrillation: enhanced case-finding in patients from general practice and evaluating three ways of irregular pulse detection. A cluster randomised trial with nested diagnostic studies - Detecting and Diagnosing Atrial Fibrillation (D2AF)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45031
Enrollment
19200
Registered
2014-11-14
Start date
2015-09-23
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arrhythmia Atrial fibrillation

Interventions

In the intervention practices we perform optimized case finding. Marked patients who visit the practice will undergo the three index tests. These tests are pulse palpation, electronic sphygmomanomet

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 65 and over Not diagnosed with atrial fibrillation

Exclusion criteria

Exclusion criteria: Legal incompetence Pacemaker Not capable of visiting the general practice

Design outcomes

Primary

MeasureTime frame
We have two primary outcomes. Firstly, we determine the difference in the number of patients with newly found AF in intervention and control practices. Secondly, we calculate sensitivity and specificity of pulse palpation, eBPM-AF and hand-ECG with the 12-lead ECG as reference standard.

Secondary

MeasureTime frame
In addition to our primary objectives, our study will address the following points. We will: * investigate the diagnostic test characteristics of the hand-ECG device for home monitoring, using the two week Holter as a reference standard. * investigate the number of patients with a regular pulse with all index tests negative for AF, in whom the two week Holter shows (paroxysmal) AF. * provide real-practice data on current pathways for AF detection in Dutch general practice (process evaluation control practices), disclosing divergence from current guidelines. * establish current AF prevalence and incidence figures in Dutch general practice. * provide patient profiles of newly detected patients with AF, including patients with *silent* paroxysmal AF. We will also explore the differences between patients with AF of Caucasian and non-Caucasian origin. * develop a prediction model for finding (different types of) AF. * determine the quality of life in patients with asymptomatic AF.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)