Graves' Disease in Remission (Disorder)NCT04333342
Heart Rate Monitoring by Wearable Devices in Graves' Disease
A study testing heart rate monitoring using wearable devices in people with Graves' Disease in Remission (Disorder), run by Seoul National University Bundang Hospital at 6 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Graves' Disease in Remission (Disorder)
- What is being tested?
- heart rate monitoring using wearable devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 22 Nov 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chungbuk National University Hospital
Cheongju-si
Chung-Ang University Hospital
Seoul
Eulji University Nowon Eulji Medical Center
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul
About this study
Official title: Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
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.
Read the 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)
- Being tested
- heart rate monitoring using wearable devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate monitoring using wearable devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable device group | Experimental | 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. Receives: Device: heart rate monitoring using wearable devices |
| Control group 1 | No intervention | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time period to detecting disease recurrence (days)
The time period to detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 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
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Measured: baseline, at the date of randomization
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Measured: 3 months
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Measured: 6 months
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
Measured: 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
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Measured: baseline, at the date of randomization
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Measured: 3 months
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Measured: 6 months
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Measured: 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
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Measured: baseline, at the date of randomization
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Measured: 3 months
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Measured: 6 months
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Measured: 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 (6)
the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 3 months
the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 6 months
the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 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
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 3 months
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 6 months
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start22 Nov 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' Disease in Remission (Disorder)Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hoon Moon, Seoul National University Bundang Hospital
- Investigators
- Jae Hoon Moon, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333342
- Sponsor's protocol ID
- B-1911/577/304
- Status last verified
- Apr 2023
- First submitted
- 11 Mar 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because of privacy issues
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
- ClinicalTrials.gov ID
- NCT04333342
- Acronym / sponsor ID
- B-1911/577/304
- Conditions
- Graves' Disease in Remission (Disorder)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wearable device group | Experimental | Device: heart rate monitoring using wearable devicesParticipants 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 | No intervention | –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 | –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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate monitoring using wearable devicesUsing 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. | Device | Wearable device group |
Primary outcome
The time period to detecting disease recurrence (days)
Time frame: 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)
Time frame: baseline, at the date of randomization
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
Time frame: 3 months
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
Time frame: 6 months
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
Time frame: 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
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
Time frame: baseline, at the date of randomization
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
Time frame: 3 months
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
Time frame: 6 months
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
Time frame: 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
thyroid function test at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Time frame: baseline, at the date of randomization
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Time frame: 3 months
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Time frame: 6 months
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Time frame: 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
Hyperthyroid Symptom Scale at the time of disease recurrence
6 secondary outcomes
the number of hospital visit until detecting disease recurrence (visit)
Time frame: 3 months
the number of hospital visit until detecting disease recurrence (visit)
Time frame: 6 months
the number of hospital visit until detecting disease recurrence (visit)
Time frame: 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
medical cost until detecting disease recurrence (KRW and USD)
Time frame: 3 months
medical cost until detecting disease recurrence (KRW and USD)
Time frame: 6 months
medical cost until detecting disease recurrence (KRW and USD)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No. IPD will not be shared because of privacy issues
Related trials for Graves' Disease in Remission (Disorder)
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Graves Disease, Graves' Disease in Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Hoon Moon, MD principal investigator
Seoul National University Bundang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart rate monitoring using wearable devices in people with Graves' Disease in Remission (Disorder), run by Seoul National University Bundang Hospital at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time period to detecting disease recurrence (days) (time frame: 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 study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.