Compliance, Medication
Conditions
Keywords
smart device, compliance monitoring, vitamin D
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.
Interventions
OTHERSelf monitoring
Self monitoring using smart clinical trial application
OTHERSmart watch assisted monitoring
Smart watch-assisted adherence monitoring
DRUGVitamin D
Vitamin D self-administration for 3 months
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
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: 1. Serum calcium level \> upper limit of normal 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of prescribed doses taken | 3 months | Percentage of doses taken |
| The percentage of days with correct dosing | 3 months | Taking adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference between administration time point and the mode of administration time point | 3 months | Timing distribution index |
| The percentage of days with correct dosing window | 3 months | Timing adherence |
| Serum concentration of vitamin D | 3 months (Day 1, 15, 29, 43, 57, 71, 85) | Vitamin D concentration |
| Sum of deviations divided by the number of days | 3 months | Concurrence of medication adherence records |
| Days without medication intake during a time period longer than 24 h | 3 months | Drug holiday |
Countries
South Korea
Outcome results
None listed