UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043222 |
|---|---|
| Receipt number | R000045884 |
| Scientific Title | Pulmonary hypertension and Telemedicine -a validity trial |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/02/02 10:00:33 |
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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
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
aoki.tatsuo@ncvc.go.jp
Sponsor or person
Institute
National Cerebral Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045884
