Clinical Feasibility of Disease-managing Mobile Application in the Patients With Hyperthyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Scores of quality of life assessed by SF-36 survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
结局指标
主要结局
Scores of quality of life assessed by SF-36 survey
时间窗: 14 weeks after baseline
Scores of quality of life assessed by SF-36 survey
antithyroidal drug compliance
时间窗: 14 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
Knowledge about hyperthyroidism
时间窗: 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
时间窗: baseline (at enrollment)
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
时间窗: 6 weeks after baseline
Scores of quality of life assessed by SF-36 survey
Scores of quality of life assessed by SF-36 survey
时间窗: 10 weeks after baseline
Scores of quality of life assessed by SF-36 survey
antithyroidal drug compliance
时间窗: 6 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
antithyroidal drug compliance
时间窗: 10 weeks after baseline
Medication adherence assessed by directly counting the remaining pills after taking the prescribed medication.
次要结局
- 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)
研究者
Jae Hoon Moon
Professor
Seoul National University Bundang Hospital