Graves' Disease in Remission (Disorder) Clinical Trial
Official title:
Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
| Verified date | April 2023 |
| Source | Seoul National University Bundang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 180 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | September 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chungbuk National University Hospital | Cheongju-si | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Eulji University Nowon Eulji Medical Center | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea Eunpyeong St. Mary's Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | baseline, at the date of randomization | |
| Primary | free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | 3 months | |
| Primary | free T4 levels (ng/dL) | thyroid function test at the time of disease recurrence | 6 months | |
| Primary | 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 | |
| Primary | TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | baseline, at the date of randomization | |
| Primary | TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | 3 months | |
| Primary | TSH levels (mIU/L) | thyroid function test at the time of disease recurrence | 6 months | |
| Primary | 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 | |
| Primary | Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | baseline, at the date of randomization | |
| Primary | Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | 3 months | |
| Primary | Hyperthyroid Symptom Scale (HSS, points) | Hyperthyroid Symptom Scale at the time of disease recurrence | 6 months | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | medical cost until detecting disease recurrence (KRW and USD) | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs | 3 months | |
| Secondary | medical cost until detecting disease recurrence (KRW and USD) | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs | 6 months | |
| Secondary | 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 |