Clinical trial NCT03009357: Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis
Official title: Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Calorie Intake by Wearable Activity Trackers in the Patients With Thyrotoxicosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyrotoxicosis
Graves Disease
Thyroiditis
Keywords: wearable activity tracker
thyrotoxicosis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status
timeFrame: continuous monitoring through the study period (average 3 months)
Secondary outcomes:
measure: Association between user-generated dietary parameters on mobile applications and the thyrotoxic status
timeFrame: continuous monitoring through the study period (average 3 months)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Hoon Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.