Status unknownNCT05828732Updated Apr 25, 2023

Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

An interventional study of Using a mobile app that integrates with wearable devices in Hyperthyroidism, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Mar 2022, registered Apr 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hyperthyroidism

Browse trials for

Hyperthyroidism 112

In context

Hyperthyroidism

112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 61 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Browse Seoul National University Bundang Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

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
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.

Interventions

OtherUsing 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.

What researchers measure

Primary outcomes

Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Time frame: baseline (at enrollment)
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Time frame: 6 weeks after baseline
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Time frame: 10 weeks after baseline
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Time frame: 14 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time frame: 6 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time frame: 10 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time frame: 14 weeks after baseline
Knowledge about hyperthyroidism
A score measured through a test designed to assess the knowledge level about Graves' disease
Time frame: 14 weeks after baseline

Secondary outcomes

free T4
serum free T4 concentration
Time frame: baseline
free T4
serum free T4 concentration
Time frame: 6 weeks after baseline
free T4
serum free T4 concentration
Time frame: 10 weeks after baseline
free T4
serum free T4 concentration
Time frame: 14 weeks after baseline
free T3
serum free T3 concentration
Time frame: baseline
free T3
serum free T3 concentration
Time frame: 6 weeks after baseline
free T3
serum free T3 concentration
Time frame: 10 weeks after baseline
free T3
serum free T3 concentration
Time frame: 14 weeks after baseline
TSH
serum free TSH concentration
Time frame: baseline
TSH
serum free TSH concentration
Time frame: 6 weeks after baseline
TSH
serum free TSH concentration
Time frame: 10 weeks after baseline
TSH
serum free TSH concentration
Time frame: 14 weeks after baseline

Study locations

1 of 1 sites recruiting

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
Recruiting
- Jae Hoon Moon, MD · Contact · jaemoon76@gmail.com · +82-31-787-7068
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05828732
Lead sponsor: Seoul National University Bundang Hospital
Collaborators: Thyroscope Inc.
Responsible party: Jae Hoon Moon (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted: Apr 25, 2023
Start date: Mar 1, 2022
Primary completion: Sep 30, 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Apr 25, 2023

Study contacts

Jae Hoon Moon, MD

Contact

jaemoon76@gmail.com

+82-31-787-7068

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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