Clinical trial NCT05828732: Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
Official title: Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperthyroidism
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: THYROSCOPE INC.
First posted: 2023-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled study aims to investigate the effects of using a mobile app that integrates with wearable devices to monitor heart rate, check self-reported symptoms, provide disease-related information, and set medication reminders for patients with thyrotoxicosis. The study intends to evaluate how the use of the app affects disease progression, quality of life, and health-related behaviors associated with the disease.


Eligibility criteria: Inclusion Criteria:

* Subjects who have been newly diagnosed or are currently undergoing treatment for thyrotoxicosis at Bundang Seoul National University Hospital.
* Subjects must be able to use the smartphone app required for the use of wearable devices and their integration.

Exclusion Criteria:

* Subjects who have constraints on normal activity due to diseases other than thyroid dysfunction.
* Subjects who are currently taking medication that affects heart rate.
* Subjects with heart conditions such as arrhythmia that affect heart rate.
* Subjects who cannot undergo antithyroid drug treatment and require surgery or radioactive iodine therapy.

Primary outcomes:
measure: Scores of quality of life assessed by SF-36 survey
timeFrame: baseline (at enrollment)
measure: Scores of quality of life assessed by SF-36 survey
timeFrame: 6 weeks after baseline
measure: Scores of quality of life assessed by SF-36 survey
timeFrame: 10 weeks after baseline
measure: Scores of quality of life assessed by SF-36 survey
timeFrame: 14 weeks after baseline
measure: antithyroidal drug compliance
timeFrame: 6 weeks after baseline
measure: antithyroidal drug compliance
timeFrame: 10 weeks after baseline
measure: antithyroidal drug compliance
timeFrame: 14 weeks after baseline
measure: Knowledge about hyperthyroidism
timeFrame: 14 weeks after baseline
Secondary outcomes:
measure: free T4
timeFrame: baseline
measure: free T4
timeFrame: 6 weeks after baseline
measure: free T4
timeFrame: 10 weeks after baseline
measure: free T4
timeFrame: 14 weeks after baseline
measure: free T3
timeFrame: baseline
measure: free T3
timeFrame: 6 weeks after baseline
measure: free T3
timeFrame: 10 weeks after baseline
measure: free T3
timeFrame: 14 weeks after baseline
measure: TSH
timeFrame: baseline
measure: TSH
timeFrame: 6 weeks after baseline
measure: TSH
timeFrame: 10 weeks after baseline
measure: TSH
timeFrame: 14 weeks after baseline
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: