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The study will investigate the effect of smart monitoring on medication adherence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self monitoring arm using smart clinical trial application | Sham Comparator | 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). |
|
| Active monitoring using smart watch coupled with self monitoring | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self monitoring | Other | Self monitoring using smart clinical trial application |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of prescribed doses taken | Percentage of doses taken | 3 months |
| The percentage of days with correct dosing | Taking adherence | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of days with correct dosing window | Timing adherence | 3 months |
| Days without medication intake during a time period longer than 24 h | Drug holiday |
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Inclusion Criteria:
Exclusion Criteria:
Hypercalciuria, sarcoidosis
Clinically significant hypersensitivity reaction to Vitamin D
History of or current kidney stone
One of the following findings:
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
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| Name | Affiliation | Role |
|---|---|---|
| Heejin Kim, PhD | Seoul National University Hospital Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| D014807 | Vitamin D |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Smart watch assisted monitoring | Other | Smart watch-assisted adherence monitoring |
|
|
| Vitamin D | Drug | Vitamin D self-administration for 3 months |
|
|
| 3 months |
| Mean difference between administration time point and the mode of administration time point | Timing distribution index | 3 months |
| Sum of deviations divided by the number of days | Concurrence of medication adherence records | 3 months |
| Serum concentration of vitamin D | Vitamin D concentration | 3 months (Day 1, 15, 29, 43, 57, 71, 85) |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |