UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025145
Receipt number R000028916
Scientific Title The research of effectiveness of telemedicine for Home care in Japan
Date of disclosure of the study information 2016/12/10
Last modified on 2018/06/11 17:31:49

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Basic information

Public title

The research of effectiveness of telemedicine for Home care in Japan

Acronym

TMJ Homes

Scientific Title

The research of effectiveness of telemedicine for Home care in Japan

Scientific Title:Acronym

TMJ Homes

Region

Japan


Condition

Condition

Symptoms of the home care

Classification by specialty

Medicine in general Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of video phone practice compared to the ordinary home care in reducing of the diagnosis time

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time to decide a diagnosis from discovering a symptom in a home care session

Key secondary outcomes

1.The QOL (EQ5D) of the patient
2.Satisfaction to the telemedicine of the doctor
3.Satisfaction to the telemedicine of the nurse
4.The difference of the number of times of the urgent visit by doctor.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In the ordinary home nursing, nurses report by telephone only for sounds or after returning to office, to ask the instructions of the doctor .
To introduce the video phone for reporting, the time before getting instructions shortens, and quality of the care improves.
The intervention period for three months, and 100 cases in total are estimated.

Interventions/Control_2

Usual home care

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Age 20 or older.
Currently home care patient.
No limitation in the disease.
Intervention by the video phone is possible.
Video phones are stably available in patients'home.

Key exclusion criteria

the patient who cannot do mutual understanding.
The patient whom it was judged a doctor to be inappropriate.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuo Sakamaki

Organization

Gunma University Hospital

Division name

System Integration Center

Zip code


Address

3-39-15 Showamachi Maebashi-City Gunma Japan

TEL

027-220-8772

Email

sakamakt@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Hasegawa

Organization

Gunma University Hospital

Division name

System Integration Center

Zip code


Address

3-39-15 Showamachi Maebashi-City Gunma Japan

TEL

027-220-8772

Homepage URL


Email

takahasegawa-mi@umin.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Ministory of Health Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

秋田厚生連 由利組合総合病院(秋田県)
医療法人イアリ 美原診療所(群馬県)
医療法人大誠会 内田病院(群馬県)
利根保健生活協同組合 とね診療所(群馬県)
つくばハートクリニック(茨城県)
医療法人篠洋会 篠崎クリニック(岡山県)
医療法人南溟会 宮上病院(鹿児島県)
日南市立中部病院(宮崎県)


Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 10 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 05 Month 31 Day

Date trial data considered complete

2017 Year 05 Month 31 Day

Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 05 Day

Last modified on

2018 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028916


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name