UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The research of effectiveness of telemedicine for Home care in Japan
Title of the study (Brief title)	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	Tetsuo Sakamaki
Organization	Gunma University Hospital
Division name	System Integration Center
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	Takashi Hasegawa
Organization	Gunma University Hospital
Division name	System Integration Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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