NCT04333342

Heart Rate Monitoring by Wearable Devices in Graves' Disease

Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graves' Disease in Remission (Disorder)

Interventions

Type	Name	Description
DEVICE	heart rate monitoring using wearable devices	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.

Timeline

• Start date: 2019-11-22
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2020-04-03
• Last updated: 2023-04-13

Locations

6 sites across 1 country: South Korea