HyperthyroidismNCT05828732
Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
A study testing Using a mobile app that integrates with wearable devices in people with Hyperthyroidism, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- Using a mobile app that integrates with wearable devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Jae Hoon Moon, MD, +82-31-787-7068, jaemoon76@gmail.com
About this study
Official title: Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
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
- Hyperthyroidism
- Being tested
- Using a mobile app that integrates with wearable devices
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a mobile app that integrates with wearable devicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| app user group | Experimental | 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. Receives: Other: Using a mobile app that integrates with wearable devices |
| non-user group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Measured: baseline (at enrollment)
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Measured: 6 weeks after baseline
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Measured: 10 weeks after baseline
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Measured: 14 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Measured: 6 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Measured: 10 weeks after baseline
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Measured: 14 weeks after baseline
Knowledge about hyperthyroidism
A score measured through a test designed to assess the knowledge level about Graves' disease
Measured: 14 weeks after baseline
Secondary outcomes (12)
free T4
serum free T4 concentration
Measured: baseline
free T4
serum free T4 concentration
Measured: 6 weeks after baseline
free T4
serum free T4 concentration
Measured: 10 weeks after baseline
free T4
serum free T4 concentration
Measured: 14 weeks after baseline
free T3
serum free T3 concentration
Measured: baseline
free T3
serum free T3 concentration
Measured: 6 weeks after baseline
free T3
serum free T3 concentration
Measured: 10 weeks after baseline
free T3
serum free T3 concentration
Measured: 14 weeks after baseline
TSH
serum free TSH concentration
Measured: baseline
TSH
serum free TSH concentration
Measured: 6 weeks after baseline
TSH
serum free TSH concentration
Measured: 10 weeks after baseline
TSH
serum free TSH concentration
Measured: 14 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Mar 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- THYROSCOPE INC.
- Responsible party
- Principal investigator, Jae Hoon Moon, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828732
- Sponsor's protocol ID
- B-2201-735-304
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT05828732
- Acronym / sponsor ID
- B-2201-735-304
- Conditions
- Hyperthyroidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- THYROSCOPE INC.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| app user group | Experimental | Other: Using a mobile app that integrates with wearable devicesThe 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. |
| non-user group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using a mobile app that integrates with wearable devicesUsing 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. | Other | app user group |
Primary outcome
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
Scores of quality of life assessed by SF-36 survey
antithyroidal drug compliance
Time frame: 6 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
antithyroidal drug compliance
Time frame: 10 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
antithyroidal drug compliance
Time frame: 14 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Knowledge about hyperthyroidism
Time frame: 14 weeks after baseline
A score measured through a test designed to assess the knowledge level about Graves' disease
12 secondary outcomes
free T4
Time frame: baseline
free T4
Time frame: 6 weeks after baseline
free T4
Time frame: 10 weeks after baseline
free T4
Time frame: 14 weeks after baseline
free T3
Time frame: baseline
free T3
Time frame: 6 weeks after baseline
free T3
Time frame: 10 weeks after baseline
free T3
Time frame: 14 weeks after baseline
TSH
Time frame: baseline
TSH
Time frame: 6 weeks after baseline
TSH
Time frame: 10 weeks after baseline
TSH
Time frame: 14 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using a mobile app that integrates with wearable devices in people with Hyperthyroidism, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hoon Moon, MD (+82-31-787-7068, jaemoon76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of quality of life assessed by SF-36 survey (time frame: baseline (at enrollment)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.