Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism

April 12, 2023 updated by: Jae Hoon Moon, Seoul National University Bundang Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (at enrollment)
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
6 weeks after baseline
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
10 weeks after baseline
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
14 weeks after baseline
antithyroidal drug compliance
Time Frame: 6 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
6 weeks after baseline
antithyroidal drug compliance
Time Frame: 10 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
10 weeks after baseline
antithyroidal drug compliance
Time Frame: 14 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
14 weeks after baseline
Knowledge about hyperthyroidism
Time Frame: 14 weeks after baseline
A score measured through a test designed to assess the knowledge level about Graves' disease
14 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
free T4
Time Frame: baseline
serum free T4 concentration
baseline
free T4
Time Frame: 6 weeks after baseline
serum free T4 concentration
6 weeks after baseline
free T4
Time Frame: 10 weeks after baseline
serum free T4 concentration
10 weeks after baseline
free T4
Time Frame: 14 weeks after baseline
serum free T4 concentration
14 weeks after baseline
free T3
Time Frame: baseline
serum free T3 concentration
baseline
free T3
Time Frame: 6 weeks after baseline
serum free T3 concentration
6 weeks after baseline
free T3
Time Frame: 10 weeks after baseline
serum free T3 concentration
10 weeks after baseline
free T3
Time Frame: 14 weeks after baseline
serum free T3 concentration
14 weeks after baseline
TSH
Time Frame: baseline
serum free TSH concentration
baseline
TSH
Time Frame: 6 weeks after baseline
serum free TSH concentration
6 weeks after baseline
TSH
Time Frame: 10 weeks after baseline
serum free TSH concentration
10 weeks after baseline
TSH
Time Frame: 14 weeks after baseline
serum free TSH concentration
14 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

THYROSCOPE INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2201-735-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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