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

Not Applicable

Completed

• Conditions: Compliance, Medication
• Interventions: Other: Self monitoring; Other: Smart watch assisted monitoring; Drug: Vitamin D

• Registration Number: NCT05452512
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-07-14
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self monitoring arm using smart clinical trial application	Self monitoring	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	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).
Active monitoring using smart watch coupled with self monitoring	Smart watch assisted 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).
Self monitoring arm using smart clinical trial application	Vitamin D	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	Vitamin D	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).

Primary Outcome Measures

Name	Time	Method
The percentage of days with correct dosing	3 months	Taking adherence
The percentage of prescribed doses taken	3 months	Percentage of doses taken

Secondary Outcome Measures

Name	Time	Method
The percentage of days with correct dosing window	3 months	Timing adherence
Mean difference between administration time point and the mode of administration time point	3 months	Timing distribution index
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
Serum concentration of vitamin D	3 months (Day 1, 15, 29, 43, 57, 71, 85)	Vitamin D concentration

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of