UMIN-CTR Clinical Trial

Basic information
Public title	Remote medicine by videophone in patients with pulmonary hypertension
Acronym	PH-TV trial
Scientific Title	Pulmonary hypertension and Telemedicine -a validity trial
Scientific Title:Acronym	PH-TV trial
Region	Japan

Condition
Condition	Pulmonary hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy of telemedicine on QOL in patients with pulmonary hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Health related quality of life assessed by SF-36 at baseline,2 months and 3 months after inclusion
Key secondary outcomes	Change in vital signs Clinical events (unexpected hospitalization and death) during study period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use of telemedicine system including videophone,sphygmomanometer, weight scale, pulse oxmeter, ECG monitor 3 months To See a patient by videophone (once per month,from day 1 to 30 and from day 61 to 90) To See a patient at outpatient clinic (once per month,from day 31 to 60)
Interventions/Control_2	control
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with pulmonary hypertension treated in our hospital (age>=18 years old)
Key exclusion criteria	Patients with permanent pacemaker
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Ogo
Organization	National Cerebral Cardiovascular Center
Division name	Cardiovascular Department
Zip code	564-8565
Address	6-1, Kishibe Shin-machi, Suita city, Osaka, Japan
TEL	06-6170-1070
Email	tak@ncvc.go.jp

Public contact
Name of contact person	1st name Tatsuo Middle name Last name Aoki
Organization	National Cerebral Cardiovascular Center
Division name	Cardiovascular Department
Zip code	564-8565
Address	6-1, Kishibe Shin-machi, Suita city, Osaka, Japan
TEL	06-6170-1070
Homepage URL
Email	aoki.tatsuo@ncvc.go.jp

Sponsor
Institute	National Cerebral Cardiovascular Center
Institute
Department

Funding Source
Organization	SECOM MEDICAL SYSTEM CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	REC
Address	6-1, Kishibe Shin-machi, Suita city, Osaka, Japan
Tel	06-6170-1070
Email	rec-office-ac@ncvc.go.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 20 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 08 Month 21 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 02 Day
Last modified on	2021 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045884