Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

Study Overview
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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.

Official Title
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Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism

Conditions
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Hyperthyroidism

Intervention / Treatment
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* Other: Using a mobile app that integrates with wearable devices


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: app user group<br>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. | Other: Using a mobile app that integrates with wearable devices<br>* 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.<br>|
| No Intervention: non-user group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of quality of life assessed by SF-36 survey | Scores of quality of life assessed by SF-36 survey | baseline (at enrollment) | 
| Scores of quality of life assessed by SF-36 survey | Scores of quality of life assessed by SF-36 survey | 6 weeks after baseline | 
| Scores of quality of life assessed by SF-36 survey | Scores of quality of life assessed by SF-36 survey | 10 weeks after baseline | 
| Scores of quality of life assessed by SF-36 survey | Scores of quality of life assessed by SF-36 survey | 14 weeks after baseline | 
| antithyroidal drug compliance | Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication. | 6 weeks after baseline | 
| antithyroidal drug compliance | Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication. | 10 weeks after baseline | 
| antithyroidal drug compliance | Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication. | 14 weeks after baseline | 
| Knowledge about hyperthyroidism | A score measured through a test designed to assess the knowledge level about Graves' disease | 14 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free T4 | serum free T4 concentration | baseline | 
| free T4 | serum free T4 concentration | 6 weeks after baseline | 
| free T4 | serum free T4 concentration | 10 weeks after baseline | 
| free T4 | serum free T4 concentration | 14 weeks after baseline | 
| free T3 | serum free T3 concentration | baseline | 
| free T3 | serum free T3 concentration | 6 weeks after baseline | 
| free T3 | serum free T3 concentration | 10 weeks after baseline | 
| free T3 | serum free T3 concentration | 14 weeks after baseline | 
| TSH | serum free TSH concentration | baseline | 
| TSH | serum free TSH concentration | 6 weeks after baseline | 
| TSH | serum free TSH concentration | 10 weeks after baseline | 
| TSH | serum free TSH concentration | 14 weeks after baseline |