Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

NCT ID: NCT05828732

Last Updated: 2023-04-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-31

Brief Summary

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This randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. The study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.

Detailed Description

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Conditions

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Hyperthyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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app user group

The participants in this group start using wearable devices to monitor their heart rate and a mobile app to assist with the management of hyperthyroidism after being diagnosed and beginning treatment with anti-thyroid medication.

Group Type EXPERIMENTAL

Using a mobile app that integrates with wearable devices

Intervention Type OTHER

Using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis.

non-user group

The participants in this group begin treatment with anti-thyroid medication after being diagnosed with thyrotoxicosis, but they do not use the wearable devices or mobile app used in this study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Using a mobile app that integrates with wearable devices

Using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at Bundang Seoul National University Hospital.
* Subjects must be able to use the smartphone app required for the use of wearable devices and their integration.

Exclusion Criteria

* Subjects who have constraints on normal activity due to diseases other than thyroid dysfunction.
* Subjects who are currently taking medication that affects heart rate.
* Subjects with heart conditions such as arrhythmia that affect heart rate.
* Subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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THYROSCOPE INC.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Hoon Moon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Hoon Moon, MD

Role: CONTACT

+82-31-787-7068

Facility Contacts

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Jae Hoon Moon, MD

Role: primary

+82-31-787-7068

Other Identifiers

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B-2201-735-304

Identifier Type: -

Identifier Source: org_study_id

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