Heart Rate Monitoring by Wearable Devices in Graves' Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Graves' Disease in Remission (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

heart rate monitoring using wearable devices

Intervention Type DEVICE

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.

Control group 1

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No