Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis (AT-thyro)

April 16, 2018 updated by: Jae Hoon Moon, Seoul National University Bundang Hospital

Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Calorie Intake by Wearable Activity Trackers in the Patients With Thyrotoxicosis

The study is a single-center prospective cohort study of clinical application of continuously monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose of the study is to evaluate the association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status along with the treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

Activity trackers to be used: Fitbit Charge HR (TM)

Data which ware provided by Fitbit app (TM) will be analyzed in this study.

Study Type

Observational

Enrollment (Actual)

40

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
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults (20 to 60 years) undergoing newly developed or recurrent thyrotoxicosis who can use wearable activity trackers and smartphone applications

Description

Inclusion Criteria:

  • Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and followed-up in Seoul National University Bundang Hospital
  • Patients who can use wearable activity trackers and smartphone applications
  • In case of Graves' disease, patients who will treated by anti-thyroid drugs

Exclusion Criteria:

  • Patients who have thyrotoxic periodic paralysis
  • In case of Graves' disease, patients who will treated by radioactive iodine therapy or thyroidectomy
  • Patients who have thyrotoxicosis due to toxic nodular disease

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

Cohorts and Interventions

Group / Cohort
thyrotoxicosis
patients with newly detected or recurrent thyrotoxicosis
control
euthyroid, healthy adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status
Time Frame: continuous monitoring through the study period (average 3 months)
continuous monitoring through the study period (average 3 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between user-generated dietary parameters on mobile applications and the thyrotoxic status
Time Frame: continuous monitoring through the study period (average 3 months)
continuous monitoring through the study period (average 3 months)

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1609/363-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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