Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting (PIAAF-FP)
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|ClinicalTrials.gov Identifier: NCT02262351|
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 9, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: 30 Second Pulse Check Device: Watch BP Home A Device: HeartCheck Hand-held ECG device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2174 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||October 15, 2016|
|Actual Study Completion Date :||December 2, 2016|
Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
Other: 30 Second Pulse Check
To detect atrial fibrillation
Device: Watch BP Home A
Blood pressure device that detects atrial fibrillation
Device: HeartCheck Hand-held ECG device
To detect atrial fibrillation
- Performance of screening tests [ Time Frame: Baseline visit ]The sensitivity and specificity of SL-ECG and BP-AF will be separately compared with that of pulse palpation alone using McNemar's method. This method can be used when only those subjects screening positive attend for confirmatory testing (12-lead ECG ± Holter monitor). A 2-sided alpha of 0.025 will be used to allow for multiple comparisons. A further analysis will be performed using the SL-ECG data as the gold standard. To ensure adequate diagnostic quality, this analysis will only be performed if 5% or less of the overall SL-ECG tracings are deemed "uninterpretable". A bipolar ECG interpreted by a cardiologist has a reported 99% sensitivity and 96% specificity for the diagnosis of AF. If this exploratory analysis is performed it will enable estimation of the sensitivity and specificity of the pulse-check and BP-AF device.
- Cost of each method per case of actionable AF detected [ Time Frame: 90 days ]
- Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints [ Time Frame: 90 days ]
- Prescription rates at 90±14 days for oral anticoagulant agents (OACs) and drugs for control of heart rate and/or rhythm for patients with actionable AF [ Time Frame: 90 days ]
- Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days. [ Time Frame: 90 days ]
- Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities). [ Time Frame: 90 days ]
- Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire. [ Time Frame: 90 days ]
- Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF. [ Time Frame: 90 days ]
- Time taken for each screening test [ Time Frame: Baseline ]
- Death rate for each case of actionable AFib identified [ Time Frame: 90 days ]
- Stroke or transient ischemic attack rate for each case of actionable AFib identified [ Time Frame: 90 days ]
- Systemic embolism rate for each case of actionable AFib identified [ Time Frame: 90 days ]
- Myocardial infarction rate rate for each case of actionable AFib identified [ Time Frame: 90 days ]
- Significant bleeding rate for each case of actionable AFib identified [ Time Frame: 90 days ]
- Hospitalization due to heart failure rate for each case of actionable AFib identified [ Time Frame: 90 days ]
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|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age ≥65 years.
- Attending their usual Primary Care Clinic.
- Provide written informed consent.
Patients considered by the Investigator to be unsuitable for study follow-up because the patient:
- is unreliable concerning the follow-up schedule
- cannot be contacted by telephone
- has a life expectancy less than the anticipated study duration due to concomitant disease.
- Presence of an implanted pacemaker or defibrillator.
- Inability to have a BP cuff applied.
- Documented significant allergy to ECG electrode adhesive.
- Previously screened as part of this study.
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): NCT02262351
|Principal Investigator:||F. Russell Quinn, MRCP PhD||University of Calgary|
|Responsible Party:||Population Health Research Institute|
|Other Study ID Numbers:||
|First Posted:||October 13, 2014 Key Record Dates|
|Last Update Posted:||October 9, 2018|
|Last Verified:||October 2018|
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