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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable device group | Experimental | 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 | No Intervention | 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. | |
| Control group 2 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heart rate monitoring using wearable devices | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Hoon Moon, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea | ||||
| Chung-Ang University Hospital |
IPD will not be shared because of privacy issues
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|
| 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 |
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 |
| Seoul |
| South Korea |
| Eulji University Nowon Eulji Medical Center | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| The Catholic University of Korea Eunpyeong St. Mary's Hospital | Seoul | South Korea |