Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib) ((DA4AFib))

November 29, 2021 updated by: Victor Montori, Mayo Clinic
To assist patients and clinicians to reach SDM about treatment options for patients with nonvalvular chronic Atrial Fibrillation screening the investigators aim to develop an evidence-based decision aid for use before the clinical encounters. Our goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about anticoagulation treatment. It should also reflect the values and preferences of the informed patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Must be 18 or older
  2. Must have an appointment for Atrial Fibrillation
  3. Must not have dementia
  4. Must not have severe hearing or vision impairment Patients will be given a written consent Guests that accompany patients will be given an oral consent KER unit PAG members will be given an oral consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA4Afib
Developing a tool to use during the encounter
We will develop a prototype from patients with atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: Immediatly following clinical visit
Decisional conflict will be measured using the decisional conflict scale
Immediatly following clinical visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Victor M Montori, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 18-007275

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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