Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- The time period to detecting disease recurrence (days)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The time period to detecting disease recurrence (days)
时间窗: 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 time period to detecting disease recurrence after discontinuing anti-thyroid drugs
free T4 levels (ng/dL)
时间窗: 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
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
时间窗: 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
thyroid function test at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
时间窗: 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 at the time of disease recurrence
次要结局
- the number of hospital visit until detecting disease recurrence (visit)(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)(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)
研究者
Jae Hoon Moon
Associate professor
Seoul National University Bundang Hospital