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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025145
Receipt No. 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

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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
Institute Gunma University
Institute
Department

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
URL(English) https://upload.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


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