Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05828732
• Collaborator: Thyroscope Inc. (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperthyroidism	Other: Using a mobile app that integrates with wearable devices	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: app user group The participants in this group start using wearable devices to monitor their heart rate and a mobile app to assist with the management of hyperthyroidism after being diagnosed and beginning treatment with anti-thyroid medication.	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.
No Intervention: non-user group The participants in this group begin treatment with anti-thyroid medication after being diagnosed with thyrotoxicosis, but they do not use the wearable devices or mobile app used in this study.

Outcome Measures

Primary Outcome Measures

1. Scores of quality of life assessed by SF-36 survey [baseline (at enrollment)]

   Scores of quality of life assessed by SF-36 survey

2. Scores of quality of life assessed by SF-36 survey [6 weeks after baseline]

   Scores of quality of life assessed by SF-36 survey

3. Scores of quality of life assessed by SF-36 survey [10 weeks after baseline]

   Scores of quality of life assessed by SF-36 survey

4. Scores of quality of life assessed by SF-36 survey [14 weeks after baseline]

   Scores of quality of life assessed by SF-36 survey

5. antithyroidal drug compliance [6 weeks after baseline]

   Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

6. antithyroidal drug compliance [10 weeks after baseline]

   Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

7. antithyroidal drug compliance [14 weeks after baseline]

   Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.

8. Knowledge about hyperthyroidism [14 weeks after baseline]

   A score measured through a test designed to assess the knowledge level about Graves' disease

Secondary Outcome Measures

1. free T4 [baseline]

   serum free T4 concentration

2. free T4 [6 weeks after baseline]

   serum free T4 concentration

3. free T4 [10 weeks after baseline]

   serum free T4 concentration

4. free T4 [14 weeks after baseline]

   serum free T4 concentration

5. free T3 [baseline]

   serum free T3 concentration

6. free T3 [6 weeks after baseline]

   serum free T3 concentration

7. free T3 [10 weeks after baseline]

   serum free T3 concentration

8. free T3 [14 weeks after baseline]

   serum free T3 concentration

9. TSH [baseline]

   serum free TSH concentration

10. TSH [6 weeks after baseline]

    serum free TSH concentration

11. TSH [10 weeks after baseline]

    serum free TSH concentration

12. TSH [14 weeks after baseline]

    serum free TSH concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital
• Thyroscope Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jae Hoon Moon, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05828732
• Other Study ID Numbers: B-2201-735-304
• First Posted: Apr 25, 2023
• Last Update Posted: Apr 25, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperthyroidism

Study Results

No Results Posted as of Apr 25, 2023