Solutions for Atrial Fibrillation Edvocacy (SAFE)

NCT05067114 | Completed

• 1 other identifier: 021
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this demonstration project is to create an additional access point in the community at local pharmacies for atrial fibrillation screening, detection, and referral to physicians for follow-up and initiation of evidence-based therapy when appropriate.

Conditions

Cardiovascular Diseases; Cardiac Arrhythmia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Completion of atrial fibrillation screenings by pharmacists

  Number of Afib screening tests performed in the pharmacy

  September through December 2021

• Abnormal rhythm detections identified by pharmacists

  Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology

  September through December 2021

• Physician referrals made by pharmacists

  Number of physician follow-up referrals made by the pharmacist

  September through December 2021

Study Arms (1)

Observational Cohort

Screening, detection, and referral for atrial fibrillation

Device: Screening, detection and referral for atrial fibrillation

Interventions

Screening, detection and referral for atrial fibrillation DEVICE

In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading

Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are at least 18 years of age who does not have a pacemaker or implantable cardioverter defibrillator (ICD) or other implanted electronic devices, is not pregnant, is not lacking capacity, and presenting to a pharmacist for usual and customary care.

You may qualify if:

• Any person at least 18 years of age
• Person who is able to present to a pharmacist for usual and customary care

You may not qualify if:

• Persons who are pregnant
• Persons who are lacking in capacity
• Persons who have a pacemaker or implantable cardioverter defibrillator (ICD) or other implanted electronic devices

Sponsors & Collaborators

• American Pharmacists Association Foundation: lead

Study Sites (1)

Central Study Sponsor Facility

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Benjamin M Bluml, Pharmacy

  American Pharmacists Association Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: September 3, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)