UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034767
Receipt No. R000039577
Official scientific title of the study Construction of new QOL evaluation method for hemophilia using accelerometer
Date of disclosure of the study information 2018/12/01
Last modified on 2018/10/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Construction of new QOL evaluation method for hemophilia using accelerometer
Title of the study (Brief title) New QOL evaluation method for hemophilia
Region
Japan

Condition
Condition hemophilia
Classification by specialty
Hematology and clinical oncology Pediatrics Orthopedics
Rehabilitation medicine Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure activity level, impact degree, movement speed, distance are recorded by an activity meter, an impact meter, and a wrist watch type GPS device to examine whether new QOL can be evaluated.
Basic objectives2 Others
Basic objectives -Others To acquire data for quality-of-life instrument
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes amount of activity, degree of impact, travel distance, transfer rate
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects are healthy volunteers and patients visiting the pediatric department in Nara medical university, persons who can walk and can wear devices for one week.
Key exclusion criteria People who are difficult to walk and people who can not act in daily life and those who can not fit the machines are excluded.
Target sample size 150

Research contact person
Name of lead principal investigator Midori Shima
Organization Nara Medical University
Division name Department of Pediatrics
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email mshima@naramed-u.ac.jp

Public contact
Name of contact person Asuka Sakata
Organization Nara Medical University
Division name Medicinal biology of thrombosis and hemostasis
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-23-9961
Homepage URL
Email asusaka@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Chugai pharmaceutical co., ltd.
Organization
Division
Category of Funding Organization Profit organization
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 奈良県立医科大学(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 09 Month 19 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Measure activity level, impact degree, movement speed, distance are recorded by an activity meter, an impact meter, and a wrist watch type GPS device to examine whether new QOL can be evaluated. The subjects are healthy volunteers and patients visiting the pediatric department in Nara medical university, persons who can walk and can wear devices for one week. People who are difficult to walk and people who can not act in daily life and those who can not fit the machines are excluded.

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.