An Open, Randomized and Parallel-design Exploratory Clinical Trial to Evaluate the Effect of Smart Medication Adherence Monitoring on the Medication Adherence and Blood Vitamin D Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The percentage of days with correct dosing
研究概览
简要总结
The study will investigate the effect of smart monitoring on medication adherence.
详细描述
In this study, multiple medication monitoring procedures will be performed: self-reporting, pill counting, smart monitoring and concentration monitoring. Subjects will take vitamin D supplement on the market which enables validated concentration monitoring. The study will last for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 19-64 years at the consent
- •25(OH) vitamin D < 10 ng/mL
- •Not taking vitamin D at the screening
- •Fully understood the study procedures
排除标准
- •Hypercalciuria, sarcoidosis
- •Clinically significant hypersensitivity reaction to Vitamin D
- •History of or current kidney stone
- •One of the following findings:
- •Serum calcium level > upper limit of normal
- •Estimated glomerular filtration rate < 60 mL/min/1.73m^2
- •Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
- •Unable to use smart clinical trial application or smart watch
- •Expected to take vitamin D from 4 weeks before the first administration and until the last administration
研究组 & 干预措施
Self monitoring arm using smart clinical trial application
The subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart clinical trial application (self monitoring).
干预措施: Self monitoring (Other)
Self monitoring arm using smart clinical trial application
The subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart clinical trial application (self monitoring).
干预措施: Vitamin D (Drug)
Active monitoring using smart watch coupled with self monitoring
The subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart watch and smart clinical trial application (self monitoring).
干预措施: Self monitoring (Other)
Active monitoring using smart watch coupled with self monitoring
The subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart watch and smart clinical trial application (self monitoring).
干预措施: Smart watch assisted monitoring (Other)
Active monitoring using smart watch coupled with self monitoring
The subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart watch and smart clinical trial application (self monitoring).
干预措施: Vitamin D (Drug)
结局指标
主要结局
The percentage of days with correct dosing
时间窗: 3 months
Taking adherence
The percentage of prescribed doses taken
时间窗: 3 months
Percentage of doses taken
次要结局
- The percentage of days with correct dosing window(3 months)
- Mean difference between administration time point and the mode of administration time point(3 months)
- Sum of deviations divided by the number of days(3 months)
- Days without medication intake during a time period longer than 24 h(3 months)
- Serum concentration of vitamin D(3 months (Day 1, 15, 29, 43, 57, 71, 85))
研究者
Kim Heejin
Research Professor
Seoul National University Hospital