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
Overview
- Phase
- Not Applicable
- Intervention
- Self monitoring
- Conditions
- Compliance, Medication
- Sponsor
- Seoul National University Hospital
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The percentage of days with correct dosing
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study will investigate the effect of smart monitoring on medication adherence.
Detailed Description
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.
Investigators
Kim Heejin
Research Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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).
Intervention: Self monitoring
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).
Intervention: Vitamin D
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).
Intervention: Self monitoring
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).
Intervention: Smart watch assisted monitoring
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).
Intervention: Vitamin D
Outcomes
Primary Outcomes
The percentage of days with correct dosing
Time Frame: 3 months
Taking adherence
The percentage of prescribed doses taken
Time Frame: 3 months
Percentage of doses taken
Secondary Outcomes
- 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))