Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

Hyperthyroidism Clinical Trial

Official title:

Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828732
• Other study ID #: B-2201-735-304
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Bundang Hospital
• Contact: Jae Hoon Moon, MD
• Phone: +82-31-787-7068
• Email: jaemoon76[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperthyroidism

Intervention

Other:
• Using a mobile app that integrates with wearable devices
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Thyroscope Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of quality of life assessed by SF-36 survey	Scores of quality of life assessed by SF-36 survey	baseline (at enrollment)
Primary	Scores of quality of life assessed by SF-36 survey	Scores of quality of life assessed by SF-36 survey	6 weeks after baseline
Primary	Scores of quality of life assessed by SF-36 survey	Scores of quality of life assessed by SF-36 survey	10 weeks after baseline
Primary	Scores of quality of life assessed by SF-36 survey	Scores of quality of life assessed by SF-36 survey	14 weeks after baseline
Primary	antithyroidal drug compliance	Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.	6 weeks after baseline
Primary	antithyroidal drug compliance	Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.	10 weeks after baseline
Primary	antithyroidal drug compliance	Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.	14 weeks after baseline
Primary	Knowledge about hyperthyroidism	A score measured through a test designed to assess the knowledge level about Graves' disease	14 weeks after baseline
Secondary	free T4	serum free T4 concentration	baseline
Secondary	free T4	serum free T4 concentration	6 weeks after baseline
Secondary	free T4	serum free T4 concentration	10 weeks after baseline
Secondary	free T4	serum free T4 concentration	14 weeks after baseline
Secondary	free T3	serum free T3 concentration	baseline
Secondary	free T3	serum free T3 concentration	6 weeks after baseline
Secondary	free T3	serum free T3 concentration	10 weeks after baseline
Secondary	free T3	serum free T3 concentration	14 weeks after baseline
Secondary	TSH	serum free TSH concentration	baseline
Secondary	TSH	serum free TSH concentration	6 weeks after baseline
Secondary	TSH	serum free TSH concentration	10 weeks after baseline
Secondary	TSH	serum free TSH concentration	14 weeks after baseline