Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Scores of quality of life assessed by SF-36 survey
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Using a mobile app that integrates with wearable devices (Other)
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.
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
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
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.
Secondary Outcomes
- free T4(14 weeks after baseline)
- free T3(14 weeks after baseline)
- TSH(14 weeks after baseline)
- free T4(baseline)
- free T4(6 weeks after baseline)
- free T4(10 weeks after baseline)
- free T3(baseline)
- free T3(6 weeks after baseline)
- free T3(10 weeks after baseline)
- TSH(baseline)
- TSH(6 weeks after baseline)
- TSH(10 weeks after baseline)
Investigators
Jae Hoon Moon
Professor
Seoul National University Bundang Hospital