UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006406 |
|---|---|
| Receipt number | R000007602 |
| Scientific Title | Comparative Study of the Convenience of the QUEST and GerdQ Questionnaires |
| Date of disclosure of the study information | 2011/09/26 |
| Last modified on | 2014/01/24 16:10:52 |
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Basic information
Public title
Comparative Study of the Convenience of the QUEST and GerdQ Questionnaires
Acronym
Comparative Study of the Convenience of the QUEST and GerdQ Questionnaires
Scientific Title
Comparative Study of the Convenience of the QUEST and GerdQ Questionnaires
Scientific Title:Acronym
Comparative Study of the Convenience of the QUEST and GerdQ Questionnaires
Region
| Japan |
Condition
Condition
Digestive system disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the convenience of the Quality-of-Life and Utility Evaluation Survey Technology (QUEST) questionnaire and the GerdQ questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time required to complete the questionnaire, whether the subjects asked any questions as they filled in the questionnaire were analyzed for evaluation of the questionnaire convinience.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects are healthy volunteers or outpatinets and hospitalized patients suffering from some digestive system disease in this study period.
Key exclusion criteria
This study excludes the subjects who were under 20 years old, disagreed with this study, had ever filled in either the QUEST or the FSSG, and could not complete the questionnaires by themselves.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Hospital
Division name
Office of Postgraduate Medical Education
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
nonaka_taka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
nonaka_taka@yahoo.co.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 09 | Month | 26 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects are randomly assigned to complete the QUEST (first) and the GerdQ(second) or the GerdQ(first) and the QUEST (second) by themselves.
The time required to complete the questionnaire, and whether the subjects asked any questions as they filled in the questionnaire are analyzed.
Management information
Registered date
| 2011 | Year | 09 | Month | 26 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007602
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
