Compliance, MedicationNCT05452512
Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch
A study testing Self monitoring, Smart watch assisted monitoring and Vitamin D in people with Compliance, Medication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The study will investigate the effect of smart monitoring on medication adherence. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Compliance, Medication
- What is being tested?
- Self monitoring, Smart watch assisted monitoring and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 03080
About this study
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
The study will investigate the effect of smart monitoring on medication adherence.
Read the detailed 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.
- Conditions
- Compliance, Medication
- Being tested
- Self monitoring, Smart watch assisted monitoring, Vitamin D
- Keywords
- smart device, compliance monitoring, vitamin D
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self monitoringOther
Also called DIARY
Self monitoring using smart clinical trial application
Smart watch assisted monitoringOther
Also called SMART WATCH
Smart watch-assisted adherence monitoring
Vitamin DDrug
Also called VITAMIN
Vitamin D self-administration for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Self monitoring; Drug: 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). Receives: Other: Self monitoring; Other: Smart watch assisted monitoring; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of prescribed doses taken
Percentage of doses taken
Measured: 3 months
The percentage of days with correct dosing
Taking adherence
Measured: 3 months
Secondary outcomes (5)
The percentage of days with correct dosing window
Timing adherence
Measured: 3 months
Days without medication intake during a time period longer than 24 h
Drug holiday
Measured: 3 months
Mean difference between administration time point and the mode of administration time point
Timing distribution index
Measured: 3 months
Sum of deviations divided by the number of days
Concurrence of medication adherence records
Measured: 3 months
Serum concentration of vitamin D
Vitamin D concentration
Measured: 3 months (Day 1, 15, 29, 43, 57, 71, 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 Jul 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, MedicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Heejin, Seoul National University Hospital
- Investigators
- Heejin Kim, PhD, Principal investigator, Seoul National University Hospital Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452512
- Sponsor's protocol ID
- SMART-DRUG-101
- Status last verified
- Mar 2023
- First submitted
- 30 May 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05452512
- Acronym / sponsor ID
- SMART-DRUG-101
- Conditions
- Compliance, Medication
- Keywords
- smart device, compliance monitoring, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate the effect of smart monitoring on medication adherence.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self monitoring arm using smart clinical trial application | Sham comparator | Other: Self monitoring, Drug: Vitamin DThe subjects in this arm will take vitamin D for 3 months and keep track of drug administration using smart clinical trial application (self monitoring). |
| Active monitoring using smart watch coupled with self monitoring | Experimental | Other: Self monitoring, Other: Smart watch assisted monitoring, Drug: Vitamin DThe 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). |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Hypercalciuria, sarcoidosis
- Clinically significant hypersensitivity reaction to Vitamin D
- History of or current kidney stone
- One of the following findings:
- Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self monitoringAlso: DIARYSelf monitoring using smart clinical trial application | Other | Active monitoring using smart watch coupled with self monitoring, Self monitoring arm using smart clinical trial application |
| Smart watch assisted monitoringAlso: SMART WATCHSmart watch-assisted adherence monitoring | Other | Active monitoring using smart watch coupled with self monitoring |
| Vitamin DAlso: VITAMINVitamin D self-administration for 3 months | Drug | Active monitoring using smart watch coupled with self monitoring, Self monitoring arm using smart clinical trial application |
Primary outcome
The percentage of prescribed doses taken
Time frame: 3 months
Percentage of doses taken
The percentage of days with correct dosing
Time frame: 3 months
Taking adherence
5 secondary outcomes
The percentage of days with correct dosing window
Time frame: 3 months
Days without medication intake during a time period longer than 24 h
Time frame: 3 months
Mean difference between administration time point and the mode of administration time point
Time frame: 3 months
Sum of deviations divided by the number of days
Time frame: 3 months
Serum concentration of vitamin D
Time frame: 3 months (Day 1, 15, 29, 43, 57, 71, 85)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heejin Kim, PhD principal investigator
Seoul National University Hospital Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self monitoring, Smart watch assisted monitoring and Vitamin D in people with Compliance, Medication, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of prescribed doses taken (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.