Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch

Study Overview
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Brief Summary
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The study will investigate the effect of smart monitoring on medication adherence.

Detailed Description
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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.

Official Title
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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

Conditions
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Compliance, Medication

Intervention / Treatment
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* Other: Self monitoring
* Other: Smart watch assisted monitoring
* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Self monitoring arm using smart clinical trial application<br>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). | Other: Self monitoring<br>* Self monitoring using smart clinical trial application<br>* Other names: DIARY;Drug: Vitamin D<br>* Vitamin D self-administration for 3 months<br>* Other names: VITAMIN;|
| Experimental: Active monitoring using smart watch coupled with self monitoring<br>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). | Other: Self monitoring<br>* Self monitoring using smart clinical trial application<br>* Other names: DIARY;Other: Smart watch assisted monitoring<br>* Smart watch-assisted adherence monitoring<br>* Other names: SMART WATCH;Drug: Vitamin D<br>* Vitamin D self-administration for 3 months<br>* Other names: VITAMIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smart device, compliance monitoring, vitamin D