Back to resultsClinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
Primary Purpose
Hyperthyroidism
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Using a mobile app that integrates with wearable devices
Sponsored by
About this trial
This is an interventional health services research trial for Hyperthyroidism
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.
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
app user group
non-user group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
antithyroidal drug compliance
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Knowledge about hyperthyroidism
A score measured through a test designed to assess the knowledge level about Graves' disease
Secondary Outcome Measures
free T4
serum free T4 concentration
free T4
serum free T4 concentration
free T4
serum free T4 concentration
free T4
serum free T4 concentration
free T3
serum free T3 concentration
free T3
serum free T3 concentration
free T3
serum free T3 concentration
free T3
serum free T3 concentration
TSH
serum free TSH concentration
TSH
serum free TSH concentration
TSH
serum free TSH concentration
TSH
serum free TSH concentration
Full Information
NCT ID
NCT05828732
First Posted
April 12, 2023
Last Updated
April 12, 2023
Sponsor
Seoul National University Bundang Hospital
Collaborators
Thyroscope Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05828732
Brief Title
Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
Official Title
Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Thyroscope Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
app user group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-user group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Using a mobile app that integrates with wearable devices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores of quality of life assessed by SF-36 survey
Description
Scores of quality of life assessed by SF-36 survey
Time Frame
baseline (at enrollment)
Title
Scores of quality of life assessed by SF-36 survey
Description
Scores of quality of life assessed by SF-36 survey
Time Frame
6 weeks after baseline
Title
Scores of quality of life assessed by SF-36 survey
Description
Scores of quality of life assessed by SF-36 survey
Time Frame
10 weeks after baseline
Title
Scores of quality of life assessed by SF-36 survey
Description
Scores of quality of life assessed by SF-36 survey
Time Frame
14 weeks after baseline
Title
antithyroidal drug compliance
Description
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time Frame
6 weeks after baseline
Title
antithyroidal drug compliance
Description
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time Frame
10 weeks after baseline
Title
antithyroidal drug compliance
Description
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Time Frame
14 weeks after baseline
Title
Knowledge about hyperthyroidism
Description
A score measured through a test designed to assess the knowledge level about Graves' disease
Time Frame
14 weeks after baseline
Secondary Outcome Measure Information:
Title
free T4
Description
serum free T4 concentration
Time Frame
baseline
Title
free T4
Description
serum free T4 concentration
Time Frame
6 weeks after baseline
Title
free T4
Description
serum free T4 concentration
Time Frame
10 weeks after baseline
Title
free T4
Description
serum free T4 concentration
Time Frame
14 weeks after baseline
Title
free T3
Description
serum free T3 concentration
Time Frame
baseline
Title
free T3
Description
serum free T3 concentration
Time Frame
6 weeks after baseline
Title
free T3
Description
serum free T3 concentration
Time Frame
10 weeks after baseline
Title
free T3
Description
serum free T3 concentration
Time Frame
14 weeks after baseline
Title
TSH
Description
serum free TSH concentration
Time Frame
baseline
Title
TSH
Description
serum free TSH concentration
Time Frame
6 weeks after baseline
Title
TSH
Description
serum free TSH concentration
Time Frame
10 weeks after baseline
Title
TSH
Description
serum free TSH concentration
Time Frame
14 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hoon Moon, MD
Phone
+82-31-787-7068
Email
jaemoon76@gmail.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Moon, MD
Phone
+82-31-787-7068
Email
jaemoon76@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Feasibility of Disease Managing Mobile App for Hyperthyroidism
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