Heart Rate Monitoring by Wearable Devices in Graves' Disease

Seoul National University

Status: Active, not recruiting

Conditions: Graves' Disease in Remission (Disorder)

Treatments: Device: heart rate monitoring using wearable devices

Study type: Interventional

Funder types: Other

Identifiers

NCT04333342

B-1911/577/304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Wearable device group

Experimental group

Description:

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.

Treatment:

Device: heart rate monitoring using wearable devices

Control group 1

No Intervention group

Description:

articipants 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

No Intervention group

Description:

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.