Back to resultsDecision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib) ((DA4AFib))
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DA4Afib Prototyping
Sponsored by
About this trial
This is an interventional health services research trial for Atrial Fibrillation
Eligibility Criteria
- Must be 18 or older
- Must have an appointment for Atrial Fibrillation
- Must not have dementia
- 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DA4Afib
Arm Description
Developing a tool to use during the encounter
Outcomes
Primary Outcome Measures
Decisional Conflict
Decisional conflict will be measured using the decisional conflict scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03744936
Brief Title
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
Acronym
(DA4AFib)
Official Title
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
February 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA4Afib
Arm Type
Experimental
Arm Description
Developing a tool to use during the encounter
Intervention Type
Other
Intervention Name(s)
DA4Afib Prototyping
Intervention Description
We will develop a prototype from patients with atrial fibrillation
Primary Outcome Measure Information:
Title
Decisional Conflict
Description
Decisional conflict will be measured using the decisional conflict scale
Time Frame
Immediatly following clinical visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Must be 18 or older
Must have an appointment for Atrial Fibrillation
Must not have dementia
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor M Montori
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
We'll reach out to this number within 24 hrs