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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03744936
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Other: DA4Afib Prototyping	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
• Actual Study Start Date: Oct 4, 2018
• Actual Primary Completion Date: Feb 6, 2020
• Actual Study Completion Date: Feb 6, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Decisional Conflict [Immediatly following clinical visit]

   Decisional conflict will be measured using the decisional conflict scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Victor M Montori, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Victor Montori, MD, Prinicpal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03744936
• Other Study ID Numbers: 18-007275
• First Posted: Nov 19, 2018
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Nov 30, 2021