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NCT04357288Completed

Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 8 Jan 2025

Brief summary (registry, in English)

This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and health outcomes for at-risk participants with Atrial Fibrillation (AF) at 6 study sites. We hypothesize the combination of the PDA and EDA will be more effective in promoting high-quality SDM and in adoption of and adherence to anticoagulation than either tool alone.

Status (registry)
Completed
Study type
Interventional
Enrollment
1117 (actual)
First submitted
13 Apr 2020
Start date
Dec 2020
Primary completion date
Sept 2024
Lead sponsor
University of Utah
NCT number
NCT04357288

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1117
  • From Dec 2020 to the primary completion date, Sept 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation
  • Have deficits in cognitive abilities or sensory input
  • Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.
    • Clinician Participants -

Who the study is looking for

  • Adults (18 and older)
  • Are diagnosed with Atrial Fibrillation
  • Are aware they have been diagnosed with Atrial Fibrillation
  • Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)
  • 1\. All clinicians (MDs, NP/PAs, PharmDs, APPs, etc.) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion.

Criteria the registry did not label

  • Patient Participants -

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Vanderbilt University
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
The Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University Of Utah Health
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.