Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

NCT03009357 — Completed, 40 participants, Seoul National University Bundang Hospital

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

Registry	NCT03009357, acronym AT-thyro
Status	Completed
Study type	Observational
Enrollment	40 (Actual)
Sponsor	Seoul National University Bundang Hospital (Other)
Conditions	Thyrotoxicosis, Graves Disease, Thyroiditis
Dates	start 2016-11-01, primary completion 2017-06-01, completion 2017-08-01, first posted 2017-01-04, last updated 2018-04-18
Locations	1 site in South Korea

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
thyrotoxicosis			patients with newly detected or recurrent thyrotoxicosis
control			euthyroid, healthy adults

+Outcome measures

Primary outcomes

Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status [continuous monitoring through the study period (average 3 months)]

Secondary outcomes

Association between user-generated dietary parameters on mobile applications and the thyrotoxic status [continuous monitoring through the study period (average 3 months)]

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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

+Locations (1)

Facility	City	Country	Status
Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do	South Korea

+Publications

Results publication: Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Monitoring Resting Heart Rate Using a Wearable Activity Tracker in Patients With Thyrotoxicosis: Prospective Longitudinal Observational Study. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e159. doi: 10.2196/mhealth.9884. PMID 30006328
Results publication: Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study. JMIR Res Protoc. 2018 Feb 21;7(2):e49. doi: 10.2196/resprot.8119. PMID 29467121

+Investigators

Jae Hoon Moon, MD, Principal investigator, Seoul National University Bundang Hospital

My Notes

Public

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