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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
180
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.
Chungbuk National University Hospital
Cheongju-si, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Eulji University Nowon Eulji Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
The time period to detecting disease recurrence (days)
The time period to detecting disease recurrence after discontinuing anti-thyroid drugs
Time frame: 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
Time frame: baseline, at the date of randomization
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Time frame: 3 months
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Time frame: 6 months
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Time frame: 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
Time frame: baseline, at the date of randomization
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Time frame: 3 months
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Time frame: 6 months
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Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Time frame: 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
Time frame: baseline, at the date of randomization
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Time frame: 3 months
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Time frame: 6 months
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Time frame: 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 (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Time frame: 6 months
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Time frame: 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