Effective Conversion of Individuals at Risk

Atrial Fibrillation Clinical Trial

Official title:

Effective Conversion of Individuals at Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05112757
• Other study ID #: ICBE-S-000283
• Status: Terminated
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2022
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

Description:

The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health

• 18 years or older, with sufficient English language skills

• Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<)

• Able to download and handle an app on a smartphone

• Willing and able to give informed consent

Exclusion criteria:

• Diagnosed with OSA and/or AFib

• Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)

• Pregnancy/breast feeding

Related Conditions & MeSH terms

• Atrial Fibrillation
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Other:
• Smartphone application use
Use of a smartphone application

Locations

Country	Name	City	State
United States	Sandford Health	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization	Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective conversion	Number of patients that visited the Primary Care Physician	6 months after consent