NCT05452512

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

May 30, 2022

Last Update Submit

March 22, 2023

Conditions

Compliance, Medication

Keywords

smart devicecompliance monitoringvitamin D

Outcome Measures

Primary Outcomes (2)

  • The percentage of prescribed doses taken

    Percentage of doses taken

    3 months

  • The percentage of days with correct dosing

    Taking adherence

    3 months

Secondary Outcomes (5)

  • The percentage of days with correct dosing window

    3 months

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

    3 months

  • Mean difference between administration time point and the mode of administration time point

    3 months

  • Sum of deviations divided by the number of days

    3 months

  • Serum concentration of vitamin D

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

Study Arms (2)

Self monitoring arm using smart clinical trial application

SHAM COMPARATOR

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 monitoringDrug: Vitamin D

Active monitoring using smart watch coupled with self monitoring

EXPERIMENTAL

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 monitoringOther: Smart watch assisted monitoringDrug: Vitamin D

Interventions

Self monitoringOTHER

Self monitoring using smart clinical trial application

Also known as: DIARY
Active monitoring using smart watch coupled with self monitoringSelf monitoring arm using smart clinical trial application
Smart watch assisted monitoringOTHER

Smart watch-assisted adherence monitoring

Also known as: SMART WATCH
Active monitoring using smart watch coupled with self monitoring
Vitamin DDRUG

Vitamin D self-administration for 3 months

Also known as: VITAMIN
Active monitoring using smart watch coupled with self monitoringSelf monitoring arm using smart clinical trial application

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 19-64 years at the consent
  • (OH) vitamin D \< 10 ng/mL
  • Not taking vitamin D at the screening
  • Fully understood the study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Blood Glucose Self-MonitoringVitamin DVitamins

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Heejin Kim, PhD

    Seoul National University Hospital Clinical Trial Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

May 30, 2022

First Posted

July 11, 2022

Study Start

July 14, 2022

Primary Completion

December 16, 2022

Study Completion

December 16, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)