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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04333342
Study type Interventional
Source Seoul National University Bundang Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 22, 2019
Completion date December 31, 2023