Skip to main content
OpenTrials
Completed

NCT Number: NCT05452512

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Compliance, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self monitoring

Other

Self monitoring using smart clinical trial application

Other names: DIARY

Smart watch assisted monitoring

Other

Smart watch-assisted adherence monitoring

Other names: SMART WATCH

Vitamin D

Drug

Vitamin D self-administration for 3 months

Other names: VITAMIN

Primary outcomes

  1. The percentage of prescribed doses taken

    Time frame: 3 months

    Percentage of doses taken

  2. The percentage of days with correct dosing

    Time frame: 3 months

    Taking adherence

Secondary outcomes

  1. The percentage of days with correct dosing window

    Time frame: 3 months

    Timing adherence

  2. Days without medication intake during a time period longer than 24 h

    Time frame: 3 months

    Drug holiday

  3. Mean difference between administration time point and the mode of administration time point

    Time frame: 3 months

    Timing distribution index

  4. Sum of deviations divided by the number of days

    Time frame: 3 months

    Concurrence of medication adherence records

  5. Serum concentration of vitamin D

    Time frame: 3 months (Day 1, 15, 29, 43, 57, 71, 85)

    Vitamin D concentration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.