Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

Not Applicable

Recruiting

• Conditions: Hyperthyroidism
• Interventions: Other: Using a mobile app that integrates with wearable devices

• Registration Number: NCT05828732
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
app user group	Using a mobile app that integrates with wearable devices	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.

Primary Outcome Measures

Name	Time	Method
Scores of quality of life assessed by SF-36 survey	14 weeks after baseline	Scores of quality of life assessed by SF-36 survey
antithyroidal drug compliance	14 weeks after baseline	Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Knowledge about hyperthyroidism	14 weeks after baseline	A score measured through a test designed to assess the knowledge level about Graves' disease

Secondary Outcome Measures

Name	Time	Method
free T4	14 weeks after baseline	serum free T4 concentration
free T3	14 weeks after baseline	serum free T3 concentration
TSH	14 weeks after baseline	serum free TSH concentration

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of