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

NCT ID: NCT05452512

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2022-12-16

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.

Conditions

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Compliance, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type SHAM_COMPARATOR

Self monitoring

Intervention Type OTHER

Self monitoring using smart clinical trial application

Vitamin D

Intervention Type DRUG

Vitamin D self-administration for 3 months

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).

Group Type EXPERIMENTAL

Self monitoring

Intervention Type OTHER

Self monitoring using smart clinical trial application

Smart watch assisted monitoring

Intervention Type OTHER

Smart watch-assisted adherence monitoring

Vitamin D

Intervention Type DRUG

Vitamin D self-administration for 3 months

Interventions

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Self monitoring

Self monitoring using smart clinical trial application

Intervention Type OTHER

Smart watch assisted monitoring

Smart watch-assisted adherence monitoring

Intervention Type OTHER

Vitamin D

Vitamin D self-administration for 3 months

Intervention Type DRUG

Other Intervention Names

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DIARY SMART WATCH VITAMIN

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:

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Heejin

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heejin Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital Clinical Trial Center

Locations

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Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMART-DRUG-101

Identifier Type: -

Identifier Source: org_study_id

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