Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting

NCT ID: NCT02262351

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-02

Brief Summary

Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.

Detailed Description

Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening

Subjects will undergo three screening methods for atrial fibrillation:

30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device

Group Type: EXPERIMENTAL

30 Second Pulse Check

Intervention Type: OTHER

To detect atrial fibrillation

Watch BP Home A

Intervention Type: DEVICE

Blood pressure device that detects atrial fibrillation

HeartCheck Hand-held ECG device

Intervention Type: DEVICE

To detect atrial fibrillation

Interventions

30 Second Pulse Check

To detect atrial fibrillation

Intervention Type: OTHER

Watch BP Home A

Blood pressure device that detects atrial fibrillation

Intervention Type: DEVICE

HeartCheck Hand-held ECG device

To detect atrial fibrillation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥65 years.

2. Attending their usual Primary Care Clinic.

3. Provide written informed consent.

Exclusion Criteria

1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient:

1. is unreliable concerning the follow-up schedule

2. cannot be contacted by telephone

3. has a life expectancy less than the anticipated study duration due to concomitant disease.

2. Presence of an implanted pacemaker or defibrillator.

3. Inability to have a BP cuff applied.

4. Documented significant allergy to ECG electrode adhesive.

5. Previously screened as part of this study.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F. Russell Quinn, MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Family Medical Centre

Black Diamond, Alberta, Canada

Crowfoot Village Family Practice

Calgary, Alberta, Canada

Smith Clinic, Camrose PCN

Camrose, Alberta, Canada

Abbottsfield Medical Centre

Edmonton, Alberta, Canada

Alta Clinical Research

Edmonton, Alberta, Canada

Edmonton Oliver PCN

Edmonton, Alberta, Canada

Peaks to Prairies PCN

Olds, Alberta, Canada

Hamilton Medical Clinic

Hamilton, Ontario, Canada

Queen's Family Health Team

Kingston, Ontario, Canada

Kirkfield Medical Centre

Kirkfield, Ontario, Canada

Ken Ng Family Practice / Total Health Management

Markham, Ontario, Canada

SKDS Research Inc

Newmarket, Ontario, Canada

Dr. Mark Robertson Family Practice

Owen Sound, Ontario, Canada

The Port Arthur Clinic Research Program

Thunder Bay, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Mount Dennis Weston Health Centre

Toronto, Ontario, Canada

Village Health Centre

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada

Countries

Canada

References

Quinn FR, Gladstone DJ, Ivers NM, Sandhu RK, Dolovich L, Ling A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Diagnostic accuracy and yield of screening tests for atrial fibrillation in the family practice setting: a multicentre cohort study. CMAJ Open. 2018 Aug 2;6(3):E308-E315. doi: 10.9778/cmajo.20180001. Print 2018 Jul-Sep.

Reference Type: RESULT

PMID: 30072410 (View on PubMed)

Tarride JE, Quinn FR, Blackhouse G, Sandhu RK, Burke N, Gladstone DJ, Ivers NM, Dolovich L, Thornton A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Is Screening for Atrial Fibrillation in Canadian Family Practices Cost-Effective in Patients 65 Years and Older? Can J Cardiol. 2018 Nov;34(11):1522-1525. doi: 10.1016/j.cjca.2018.05.016. Epub 2018 Jun 21.

Reference Type: RESULT

PMID: 30144961 (View on PubMed)

Other Identifiers

PIAAF-FP

Identifier Type: -

Identifier Source: org_study_id