Decentralized Clinical Trial Simulation Study -A Study on Decentralized Clinical Trial Methods-

JRCT ID: jRCT1030220469

Registered date:28/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes mellitus
• Date of first enrollment: 01/12/2022
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Part 1 No intervention,Part 2 Investigate subjective symptoms, objective findings, compliance of medications and status of foot self-care once by telemedicine

Outcome(s)

Primary Outcome

Subjects' Impressions of remote informed consent with eConsent system
Subjects' Impressions of patient report about foot self-care with ePRO system
Subjects' Impressions of virtual visit (telemedicine)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Part 1
- Patients who have been seen at Kodaira Hospital
- Patients aged >=18 at the time of informed consent
Part 2
- Patients who have been seen at Kodaira Hospital
- Patients who have been diagnosed with diabetes melllitus, and conducting self-foot care for the prevention of diabetic foot, or were to be capable to conduct self foot care judged by investigators
- Patients aged >=18 at the time of informed consent

Exclude criteria

Part 1
- Patients who participated in Part 1 and gave answers to the questionnaire
- Patients who do not have the Internet connection
Part 2
- Patients who participated in Part 2
- Patients who have been judged by investigators to have difficulty in using devices and systems for DCT methods and in e-mail communication

Related Information

• Primary Sponsor: Nagao Noriaki