Heart Rate Monitoring by Wearable Devices in Graves' Disease

Study Overview
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Brief Summary
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A multi center randomized controlled study including 3 arms (wearable device group, control group 1, control group 2). This study is to investigate clinical feasibility of heart rate monitoring using wearable devices to detect disease recurrence in the patients who discontinue anti-thyroid drugs in remission state.

Detailed Description
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A multi center randomized controlled study including 3 arms (wearable device group, control group 1, control group 2). Study participants: Patients with Graves' disease who are planned to discontinue anti-thyroid drugs in remission state Wearable device group: Participants use wearable device and their heart rate and activity are monitored. If their resting heart rate (rHR) increase beyond the set range or they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If their rHR stay within set range and they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs. Control group 1: Participants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs. Control group 2: Participants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 3 and 6 months after discontinuing anti-thyroid drugs. A period to detecting disease recurrence, thyroid function test and Hyperthyroid Symptom Scale (HSS) at the time of disease recurrence, and the number of hospital visit and medical cost until detecting disease recurrence will be compared among 3 groups.

Official Title
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Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs

Conditions
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Graves' Disease in Remission (Disorder)

Intervention / Treatment
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* Device: heart rate monitoring using wearable devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Graves' disease who are being treated with anti-thyroid drugs (ATDs) and planned to discontinue ATDs Those who have who have continued to administer ATDs for more than 1 year Those who showed normal findings on thyroid function tests while maintaining stable doses of ATDs in the last 3 months Those who can use wearable devices and smartphone apps to work with during the research period Exclusion Criteria: Those with heart disease, such as arrhythmia, that can affect heart rate Those who are taking medications that may affect their heart rate Those who researchers deemed unsuitable for participation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable device group<br>Participants use wearable device and their heart rate and activity are monitored. If their resting heart rate (rHR) increase beyond the set range or they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If their rHR stay within set range and they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs. | Device: heart rate monitoring using wearable devices<br>* Using Fitbit (TM) wearable devices, heart rate, activity data are collected. Based on these data, resting heart rate is monitored daily basis. If resting heart rate increase beyond set range, users are notified to visit the hospital.<br>|
| No Intervention: Control group 1<br>articipants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 6 months after discontinuing anti-thyroid drugs. | |
| No Intervention: Control group 2<br>Participants don't use wearable devices. If they have hyperthyroid symptoms and signs, they should come to the hospital and get tests for thyroid function. If they have no symptoms and signs, they come to hospital and get tests for thyroid function 3 and 6 months after discontinuing anti-thyroid drugs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time period to detecting disease recurrence (days) | The time period to detecting disease recurrence after discontinuing anti-thyroid drugs | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days | 
| free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | baseline, at the date of randomization | 
| free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | 3 months | 
| free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | 6 months | 
| free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days | 
| TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | baseline, at the date of randomization | 
| TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | 3 months | 
| TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | 6 months | 
| TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days | 
| Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | baseline, at the date of randomization | 
| Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | 3 months | 
| Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | 6 months | 
| Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of hospital visit until detecting disease recurrence (visit) | the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs | 3 months | 
| the number of hospital visit until detecting disease recurrence (visit) | the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs | 6 months | 
| the number of hospital visit until detecting disease recurrence (visit) | the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days | 
| medical cost until detecting disease recurrence (KRW and USD) | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs | 3 months | 
| medical cost until detecting disease recurrence (KRW and USD) | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs | 6 months | 
| medical cost until detecting disease recurrence (KRW and USD) | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs | at the time of disease recurrence, from date of randomization until the date of first documented recurrence of Graves' disease by thyroid function test, assessed up to 180 days |