Heart Rate Monitoring by Wearable Devices in Graves' Disease
- Conditions
- Graves' Disease in Remission (Disorder)
- Interventions
- Device: heart rate monitoring using wearable devices
- Registration Number
- NCT04333342
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wearable device group heart rate monitoring using wearable devices 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.
- Primary Outcome Measures
Name Time Method The time period to detecting disease recurrence (days) 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) 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) 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) 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
- Secondary Outcome Measures
Name Time Method 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 the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
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 medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Trial Locations
- Locations (6)
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Eulji University Nowon Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of