Graves' Disease in Remission (Disorder)
Conditions
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.
Interventions
DEVICEheart 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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | baseline, at the date of randomization | thyroid function test at the time of disease recurrence |
| TSH levels (mIU/L) | baseline, at the date of randomization | thyroid function test at the time of disease recurrence |
| Hyperthyroid Symptom Scale (HSS, points) | baseline, at the date of randomization | Hyperthyroid Symptom Scale at the time of disease recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the number of hospital visit until detecting disease recurrence (visit) | 3 months | the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs |
| medical cost until detecting disease recurrence (KRW and USD) | 3 months | medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs |
Countries
South Korea
Outcome results
None listed