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Clinical Trials/NCT05828732
NCT05828732
Recruiting
N/A

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

Seoul National University Bundang Hospital1 site in 1 country100 target enrollmentMarch 1, 2022
ConditionsHyperthyroidism

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hyperthyroidism
Sponsor
Seoul National University Bundang Hospital
Enrollment
100
Locations
1
Primary Endpoint
Scores of quality of life assessed by SF-36 survey
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jae Hoon Moon

Professor

Seoul National University Bundang Hospital

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.

Outcomes

Primary Outcomes

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: 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

Secondary Outcomes

  • free T4(14 weeks after baseline)
  • free T3(14 weeks after baseline)
  • TSH(14 weeks after baseline)

Study Sites (1)

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