臨床研究等提出・公開システム

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

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

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Part 1: The average age of the participants was 52.9 years, with the age distribution centered around the 50s. Questionnaire results were obtained from age groups ranging from young to elderly. A total of 56 males and 55 females responded to the questionnaire. No other notable findings regarding the baseline characteristics were observed. Part 2: The average age of the participants was 55.6 years. 7 males and 3 females participated in Part 2.No other notable findings regarding the baseline characteristics were observed.

Part 1: There were 147 eligible participants, 137 participants who were sent the questionnaire, and 101 participants who responded to it. Part 2: 10 participants were enrolled in Part 2, one of whom was discontinued.

Since this research was a quastionnaire survey, no safety evaluations were performed.

Part 1: About 56% of the participants answered "agree" or "somewhat agree" to the statement that they would like to be able to receive explanations and consent for clinical trials from remote locations other than clinical trial sites. About 73% of the participants answered "useful" or "somewhat useful" to the statement that having clinical trial investigations conducted through telemedicine would reduce the number of visits to trial sites. About 25% of the participants indicated that they would feel uncomfortable or anxious about having a nurse visit their homes to perform medical examinations and investigations required for clinical trials. Part 2: All 5 participants who received remote informed consent indicated that they had no concerns about the communication environment or communication during the remote explanation and consent process. Seven of the nine participants who experienced telemedicine indicated that they had no concerns about the communication environment or communication during the virtual visit. Six of the nine participants indicated that they would be willing to continue using telemedicine to receive clinical trial investigations in the future.

Patients' impressions regarding the methods used in decentralized clinical trials could be confirmed, targeting outpatients.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1030220469

Nagao Noriaki

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan

clinicaltrials-info@shionogi.co.jp

clinical trials information

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan

+81-3-6635-3505

clinicaltrials-info@shionogi.co.jp

Complete

Nov. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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

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

Both

Diabetes mellitus

Part 1 No intervention,Part 2 Investigate subjective symptoms, objective findings, compliance of medications and status of foot self-care once by telemedicine

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)

Oct. 20, 2022

none