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

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

The study will investigate the effect of smart monitoring on medication adherence.

Study Overview

• Status: Completed
• Conditions: Compliance, Medication
• Intervention / Treatment: Other: Self monitoring; Drug: Vitamin D; Other: Smart watch assisted monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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).	Other: Self monitoring; Self monitoring using smart clinical trial application; Other Names: DIARY; Drug: Vitamin D; Vitamin D self-administration for 3 months; Other Names: VITAMIN
Experimental: 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).	Other: Self monitoring; Self monitoring using smart clinical trial application; Other Names: DIARY; Drug: Vitamin D; Vitamin D self-administration for 3 months; Other Names: VITAMIN; Other: Smart watch assisted monitoring; Smart watch-assisted adherence monitoring; Other Names: SMART WATCH

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: vitamin D; smart device; compliance monitoring
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Vitamin D; Vitamins
• Other Study ID Numbers: SMART-DRUG-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No