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Heart Rate Monitoring by Wearable Devices in Graves' Disease

Primary Purpose

Graves' Disease in Remission (Disorder)

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
heart rate monitoring using wearable devices
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Graves' Disease in Remission (Disorder)

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Wearable device group

Control group 1

Control group 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The time period to detecting disease recurrence (days)
The time period to detecting disease recurrence after discontinuing anti-thyroid drugs
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
free T4 levels (ng/dL)
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
TSH levels (mIU/L)
thyroid function test at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence
Hyperthyroid Symptom Scale (HSS, points)
Hyperthyroid Symptom Scale at the time of disease recurrence

Secondary Outcome Measures

the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
the number of hospital visit until detecting disease recurrence (visit)
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
medical cost until detecting disease recurrence (KRW and USD)
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs

Full Information

First Posted
March 11, 2020
Last Updated
April 11, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04333342
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Disease in Remission (Disorder)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearable device group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group 1
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control group 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
heart rate monitoring using wearable devices
Intervention Description
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.
Primary Outcome Measure Information:
Title
The time period to detecting disease recurrence (days)
Description
The time period to detecting disease recurrence after discontinuing anti-thyroid drugs
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
Title
free T4 levels (ng/dL)
Description
thyroid function test at the time of disease recurrence
Time Frame
baseline, at the date of randomization
Title
free T4 levels (ng/dL)
Description
thyroid function test at the time of disease recurrence
Time Frame
3 months
Title
free T4 levels (ng/dL)
Description
thyroid function test at the time of disease recurrence
Time Frame
6 months
Title
free T4 levels (ng/dL)
Description
thyroid function test at the time of disease recurrence
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
Title
TSH levels (mIU/L)
Description
thyroid function test at the time of disease recurrence
Time Frame
baseline, at the date of randomization
Title
TSH levels (mIU/L)
Description
thyroid function test at the time of disease recurrence
Time Frame
3 months
Title
TSH levels (mIU/L)
Description
thyroid function test at the time of disease recurrence
Time Frame
6 months
Title
TSH levels (mIU/L)
Description
thyroid function test at the time of disease recurrence
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
Title
Hyperthyroid Symptom Scale (HSS, points)
Description
Hyperthyroid Symptom Scale at the time of disease recurrence
Time Frame
baseline, at the date of randomization
Title
Hyperthyroid Symptom Scale (HSS, points)
Description
Hyperthyroid Symptom Scale at the time of disease recurrence
Time Frame
3 months
Title
Hyperthyroid Symptom Scale (HSS, points)
Description
Hyperthyroid Symptom Scale at the time of disease recurrence
Time Frame
6 months
Title
Hyperthyroid Symptom Scale (HSS, points)
Description
Hyperthyroid Symptom Scale at the time of disease recurrence
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
Secondary Outcome Measure Information:
Title
the number of hospital visit until detecting disease recurrence (visit)
Description
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Time Frame
3 months
Title
the number of hospital visit until detecting disease recurrence (visit)
Description
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
Time Frame
6 months
Title
the number of hospital visit until detecting disease recurrence (visit)
Description
the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs
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
Title
medical cost until detecting disease recurrence (KRW and USD)
Description
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Time Frame
3 months
Title
medical cost until detecting disease recurrence (KRW and USD)
Description
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
Time Frame
6 months
Title
medical cost until detecting disease recurrence (KRW and USD)
Description
medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Moon, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji University Nowon Eulji Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared because of privacy issues

Learn more about this trial

Heart Rate Monitoring by Wearable Devices in Graves' Disease

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