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Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention (ENHANCE-AF)

Stanford University logo

Stanford University

Status

Completed

Conditions

Arrhythmia
Atrial Flutter
Atrial Fibrillation
Cardiac
Stroke
Heart Failure

Treatments

Behavioral: SDMT
Behavioral: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention

Full description

This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.

Enrollment

1,001 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 y/o

  • Non-valvular atrial fibrillation or atrial flutter (AFib)

  • CHA2DS2-VASc stroke score of:

    • Men: 1 or more
    • Women: 2 or more
  • Able to consent in English or Spanish (if resources allow) and follow study instructions

Exclusion criteria

  • Moderate to severe mitral stenosis
  • Mechanical valve replacement
  • Absolute contraindication to anticoagulation (Based on clinician judgment)
  • Indication for anticoagulation therapy for a condition other than atrial fibrillation
  • Left atrial appendage exclusion (by surgery or device placement)
  • At the clinical discretion of the investigator

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,001 participants in 2 patient groups

Shared Decision Making Tool (SDMT)
Experimental group
Treatment:
Behavioral: SDMT
Usual Care
Active Comparator group
Treatment:
Behavioral: Usual Care

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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