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Effective Conversion of Individuals at Risk

NCT ID: NCT05112757

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2022-12-08

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Atrial Fibrillation

Keywords

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OSA AFib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Smartphone app use

Group Type EXPERIMENTAL

Smartphone application use

Intervention Type OTHER

Use of a smartphone application

Interventions

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Smartphone application use

Use of a smartphone application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanford Health

OTHER

Sponsor Role collaborator

Philips Electronics Nederland B.V. acting through Philips CTO organization

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Weysen, MSc

Role: PRINCIPAL_INVESTIGATOR

Philips Healthcare

Locations

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Sandford Health

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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ICBE-S-000283

Identifier Type: -

Identifier Source: org_study_id