Back to resultsStudy to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
Primary Purpose
COVID-19 Pneumonia
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual investigational product
Sponsored by
About this trial
This is an interventional basic science trial for COVID-19 Pneumonia focused on measuring blockchain, dynamic consent
Eligibility Criteria
Inclusion Criteria:
- Subjects who can use METORY (application platform)
- Subjects who completely understand the study and voluntarily decide to participate in the study
Exclusion Criteria:
- Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
- Subjects who are not able to measure body temperature by themselves
- Subjects who investigators decide not be appropriate for the study for other reasons
Sites / Locations
- Jeonbuk National University Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dynamic consent arm
Arm Description
Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint.
Outcomes
Primary Outcome Measures
Response time
The time interval between notification of protocol amendment and subjects' response (consent)
Secondary Outcome Measures
Study completion rate
The proportion of subjects who completed the study
Dropout rate
The proportion of subjects who withdrew the study
Full Information
NCT ID
NCT05047016
First Posted
September 8, 2021
Last Updated
November 4, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05047016
Brief Title
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
Official Title
A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.
Detailed Description
The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
blockchain, dynamic consent
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic consent arm
Arm Type
Other
Arm Description
Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint.
Intervention Type
Other
Intervention Name(s)
Virtual investigational product
Intervention Description
The virtual investigational product is a predefined text (e.g. AB123F). By entering the code into the application, the virtual 'administration' of the IP is conducted.
Primary Outcome Measure Information:
Title
Response time
Description
The time interval between notification of protocol amendment and subjects' response (consent)
Time Frame
Study Period of 4 weeks
Secondary Outcome Measure Information:
Title
Study completion rate
Description
The proportion of subjects who completed the study
Time Frame
Study Period of 4 weeks
Title
Dropout rate
Description
The proportion of subjects who withdrew the study
Time Frame
Study Period of 4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who can use METORY (application platform)
Subjects who completely understand the study and voluntarily decide to participate in the study
Exclusion Criteria:
Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
Subjects who are not able to measure body temperature by themselves
Subjects who investigators decide not be appropriate for the study for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
We'll reach out to this number within 24 hrs