Clinical trial NCT04333342: Heart Rate Monitoring by Wearable Devices in Graves' Disease
Official title: Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graves' Disease in Remission (Disorder)
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The time period to detecting disease recurrence (days)
timeFrame: 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
measure: free T4 levels (ng/dL)
timeFrame: baseline, at the date of randomization
measure: free T4 levels (ng/dL)
timeFrame: 3 months
measure: free T4 levels (ng/dL)
timeFrame: 6 months
measure: free T4 levels (ng/dL)
timeFrame: 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
measure: TSH levels (mIU/L)
timeFrame: baseline, at the date of randomization
measure: TSH levels (mIU/L)
timeFrame: 3 months
measure: TSH levels (mIU/L)
timeFrame: 6 months
measure: TSH levels (mIU/L)
timeFrame: 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
measure: Hyperthyroid Symptom Scale (HSS, points)
timeFrame: baseline, at the date of randomization
measure: Hyperthyroid Symptom Scale (HSS, points)
timeFrame: 3 months
measure: Hyperthyroid Symptom Scale (HSS, points)
timeFrame: 6 months
measure: Hyperthyroid Symptom Scale (HSS, points)
timeFrame: 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
Secondary outcomes:
measure: the number of hospital visit until detecting disease recurrence (visit)
timeFrame: 3 months
measure: the number of hospital visit until detecting disease recurrence (visit)
timeFrame: 6 months
measure: the number of hospital visit until detecting disease recurrence (visit)
timeFrame: 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
measure: medical cost until detecting disease recurrence (KRW and USD)
timeFrame: 3 months
measure: medical cost until detecting disease recurrence (KRW and USD)
timeFrame: 6 months
measure: medical cost until detecting disease recurrence (KRW and USD)
timeFrame: 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
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji University Nowon Eulji Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St. Mary's Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Hoon Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: