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

NCT03744936 | Completed Results

• 1 other identifier: 18-007275
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Interview Process

  The number of subjects to complete the interview process

  baseline

Study Arms (1)

Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

Subjects who are scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota

Other: Feedback

Interventions

Feedback OTHER

Study team members will conduct interviews with subjects to gather feedback on Atrial Fibrillation experiences

Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Encounters of subjects scheduled for AF (Atrial Fibrillation) treatment will be observed (by a study team member and/or using a video recording device) at Mayo Clinic Rochester and may be observed at Mayo Clinic Health System sites in Minnesota.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• American Heart Association: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Jones AE, McCarty MM, Cameron KA, Cavanaugh KL, Steinberg BA, Passman R, Kansal P, Guzman A, Chen E, Zhong L, Fagerlin A, Hargraves I, Montori VM, Brito JP, Noseworthy PA, Ozanne EM. Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation. MDM Policy Pract. 2023 Jun 21;8(1):23814683231178033. doi: 10.1177/23814683231178033. eCollection 2023 Jan-Jun.

  PMID: 38178866 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Victor Montori
• Organization: Mayo Clinic

montori.victor@gmail.com

507-284-1920

Study Officials

• Victor M Montori

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prinicpal Investigator

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 19, 2018
• Study Start: October 4, 2018
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)