UMIN-CTR Clinical Trial

Public title

Investigation of Factors Inhibiting the Spread of Telemedicine in Japan

Acronym

Investigation of Factors Inhibiting the Spread of Telemedicine in Japan

Scientific Title

Investigation of Factors Inhibiting the Spread of Telemedicine in Japan

Scientific Title:Acronym

Investigation of Factors Inhibiting the Spread of Telemedicine in Japan

Region

Japan

Condition

No target disease set.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Online medical care has developed in recent years with the development of the Internet and web conferencing systems, and the spread of online medical care has been remarkable in other countries due to the spread of COVID-19. In Japan, on the other hand, online medical care is actively practiced in some clinics, but it is not yet widespread nationwide. Online medical services are expected to play an important role in the future of healthcare, and it is important to detect factors that inhibit the spread of online medical services in Japan in order to make appropriate policy recommendations for the future spread of online medical services. Therefore, this study examines the factors that hinder the spread of online medical care in Japan from the perspectives of healthcare professionals (physicians, nurses, etc.), administrative personnel (including managers), and patients.

Basic objectives2

Others

Basic objectives -Others

This study does not involve intervention and does not look at the safety, efficacy, or biological safety of drugs or other interventions.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Identification of factors that inhibit online medical care in Japan.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

[Interview survey]
Patients | Patients or family members of patients attending a collaborative research institutions, including the lead institution, whose attending physicians have determined that they can be interviewed.
Medical and administrative staff | Medical or administrative staff working at the collaborating research institutions, including the lead institutions.

[Questionnaire survey targeting healthcare professionals and administrative staff]
Medical personnel (limited to physicians, nurses, public health nurses, and midwives) and administrative personnel working at approximately 5,000 facilities randomly selected from Japanese medical facilities (179,331 facilities as of the end of January 2021) (stratified according to attributes, with the possibility of adjusting the proportion of core hospitals and university hospitals).

[Questionnaire survey of patients and healthy subjects]
The Freeasy cohort will be screened for inclusion in this study, and those who responded to the screening survey and can be identified as either healthy subjects or patients (including patients' family members) in the screening questionnaire will be included in the study.

Key exclusion criteria

In any survey, under 20 years of age.

Target sample size

36120

Name of lead principal investigator

1st name	Yosuke
Middle name
Last name	Hirakawa

Organization

The University of Tokyo Hospital

Division name

Division of Nephrology and Endocrinology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN

TEL

03-3815-5411

Email

yhirakawa@g.ecc.u-tokyo.ac.jp

Name of contact person

1st name	Shuhei
Middle name
Last name	Mitani

Organization

The University of Tokyo Hospital

Division name

Division of Nephrology and Endocrinology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5800-8969

Homepage URL

Email

mitaniriae@gmail.com

Institute

The University of Tokyo Hospital

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of the Faculty of Medicine of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

05

Month

01

Day

Date of IRB

2023

Year

05

Month

19

Day

Anticipated trial start date

2023

Year

05

Month

22

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

[Interview survey]
Interviews will be conducted with patients, healthcare professionals, and administrative staff at the collaborating institutions, including the lead institution, to obtain their opinions on practical issues and other issues related to online medical care. The interviews will be conducted in person, and the results will be collected on a PC as a verbatim record. The survey results will be used for setting of questions for questionnaire survey.
[Questionnaire survey targeting healthcare professionals and administrative staff]
A questionnaire survey on disincentive for introduction/promotion of telemedicine will be conducted among healthcare professionals and administrative staff nationwide. Specifically, medical professionals and administrative staff working at approximately 5,000 facilities randomly selected from insured medical institutions in Japan will be targeted, and three medical professionals and three administrative staff per facility will be asked to respond. Responses will be aggregated and statistically analyzed as appropriate.
[Questionnaire survey of patients and healthy subjects]
A web-based questionnaire survey will be conducted among patients or healthy persons in the Freeasy cohort (iBRIDGE Corporation) to identify factors that may hinder the introduction/promotion of telemedicine. After the screening, approx. 3,000 persons per group randomly selected from each of these groups will be asked to participate in the survey on the questionnaire site. The responses will be aggregated and statistically analyzed as appropriate.

Registered date

2023

Year

06

Month

01

Day

Last modified on

2023

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058322