Heart Rate Monitoring by Wearable Devices in Graves' Disease

April 11, 2023 updated by: Jae Hoon Moon, Seoul National University Bundang Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Eunpyeong St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Eulji University Nowon Eulji Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: baseline, at the date of randomization
thyroid function test at the time of disease recurrence
baseline, at the date of randomization
free T4 levels (ng/dL)
Time Frame: 3 months
thyroid function test at the time of disease recurrence
3 months
free T4 levels (ng/dL)
Time Frame: 6 months
thyroid function test at the time of disease recurrence
6 months
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
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)
Time Frame: baseline, at the date of randomization
thyroid function test at the time of disease recurrence
baseline, at the date of randomization
TSH levels (mIU/L)
Time Frame: 3 months
thyroid function test at the time of disease recurrence
3 months
TSH levels (mIU/L)
Time Frame: 6 months
thyroid function test at the time of disease recurrence
6 months
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
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)
Time Frame: baseline, at the date of randomization
Hyperthyroid Symptom Scale at the time of disease recurrence
baseline, at the date of randomization
Hyperthyroid Symptom Scale (HSS, points)
Time Frame: 3 months
Hyperthyroid Symptom Scale at the time of disease recurrence
3 months
Hyperthyroid Symptom Scale (HSS, points)
Time Frame: 6 months
Hyperthyroid Symptom Scale at the time of disease recurrence
6 months
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of hospital visit until detecting disease recurrence (visit)
Time Frame: 3 months
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
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 after discontinuing anti-thyroid drugs
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
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
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 after discontinuing anti-thyroid drugs
3 months
medical cost until detecting disease recurrence (KRW and USD)
Time Frame: 6 months
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
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
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1911/577/304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because of privacy issues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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