Heart Rate Monitoring by Wearable Devices in Graves' Disease

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04333342
Collaborator
(none)
180
6
3
25.3
30
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: heart rate monitoring using wearable devices
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Usefulness of Monitoring Heart Rate Using Wearable Devices in the Patients of Graves' Disease Who Discontinue Anti-thyroid Drugs
Actual Study Start Date :
Nov 22, 2019
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. free T4 levels (ng/dL) [baseline, at the date of randomization]

    thyroid function test at the time of disease recurrence

  3. free T4 levels (ng/dL) [3 months]

    thyroid function test at the time of disease recurrence

  4. free T4 levels (ng/dL) [6 months]

    thyroid function test at the time of disease recurrence

  5. free T4 levels (ng/dL) [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

  6. TSH levels (mIU/L) [baseline, at the date of randomization]

    thyroid function test at the time of disease recurrence

  7. TSH levels (mIU/L) [3 months]

    thyroid function test at the time of disease recurrence

  8. TSH levels (mIU/L) [6 months]

    thyroid function test at the time of disease recurrence

  9. TSH levels (mIU/L) [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

  10. Hyperthyroid Symptom Scale (HSS, points) [baseline, at the date of randomization]

    Hyperthyroid Symptom Scale at the time of disease recurrence

  11. Hyperthyroid Symptom Scale (HSS, points) [3 months]

    Hyperthyroid Symptom Scale at the time of disease recurrence

  12. Hyperthyroid Symptom Scale (HSS, points) [6 months]

    Hyperthyroid Symptom Scale at the time of disease recurrence

  13. Hyperthyroid Symptom Scale (HSS, points) [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

Secondary Outcome Measures

  1. 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

  2. the number of hospital visit until detecting disease recurrence (visit) [6 months]

    the number of hospital visit until detecting disease recurrence after discontinuing anti-thyroid drugs

  3. the number of hospital visit until detecting disease recurrence (visit) [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

  4. medical cost until detecting disease recurrence (KRW and USD) [3 months]

    medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs

  5. medical cost until detecting disease recurrence (KRW and USD) [6 months]

    medical cost until detecting disease recurrence after discontinuing anti-thyroid drugs

  6. medical cost until detecting disease recurrence (KRW and USD) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chungbuk National University Hospital Cheongju-si Korea, Republic of
2 Chung-Ang University Hospital Seoul Korea, Republic of
3 Eulji University Nowon Eulji Medical Center Seoul Korea, Republic of
4 Korea University Guro Hospital Seoul Korea, Republic of
5 Seoul National University Hospital Seoul Korea, Republic of
6 The Catholic University of Korea Eunpyeong St. Mary's Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jae Hoon Moon, MD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jae Hoon Moon, Associate professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT04333342
Other Study ID Numbers:
  • B-1911/577/304
First Posted:
Apr 3, 2020
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021