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

Compliance, Medication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452512
• Other study ID #: SMART-DRUG-101
• Status: Completed
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: March 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Medication

Intervention

Other:
• Self monitoring
Self monitoring using smart clinical trial application
• Smart watch assisted monitoring
Smart watch-assisted adherence monitoring

Drug:
• Vitamin D
Vitamin D self-administration for 3 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of prescribed doses taken	Percentage of doses taken	3 months
Primary	The percentage of days with correct dosing	Taking adherence	3 months
Secondary	The percentage of days with correct dosing window	Timing adherence	3 months
Secondary	Days without medication intake during a time period longer than 24 h	Drug holiday	3 months
Secondary	Mean difference between administration time point and the mode of administration time point	Timing distribution index	3 months
Secondary	Sum of deviations divided by the number of days	Concurrence of medication adherence records	3 months
Secondary	Serum concentration of vitamin D	Vitamin D concentration	3 months (Day 1, 15, 29, 43, 57, 71, 85)