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

Seoul National University

Status: Completed

Conditions: Compliance, Medication

Treatments: Other: Smart watch assisted monitoring; Other: Self monitoring; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05452512

SMART-DRUG-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Self monitoring arm using smart clinical trial application

Sham Comparator group

Description:

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).

Treatment:

Drug: Vitamin D

Other: Self monitoring

Active monitoring using smart watch coupled with self monitoring

Experimental group

Description:

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).

Treatment:

Drug: Vitamin D

Other: Self monitoring

Other: Smart watch assisted monitoring