UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041942 |
|---|---|
| Receipt number | R000047830 |
| Scientific Title | Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2022/03/31 23:23:55 |
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Basic information
Public title
Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Acronym
Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Scientific Title
Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Scientific Title:Acronym
Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Region
| Japan |
Condition
Condition
All diseases; patients who have been issued prescriptions for treatment
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the change of health-related QOL during treatment
Basic objectives2
Others
Basic objectives -Others
Clarify adverse events affecting health-related QOL
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
An observation period of 6 months or more will be provided from the start of registration. Health-related QOL is measured 4 or more times during the observation period. The primary endpoint is quality-adjusted life years (QALY).
Key secondary outcomes
Adverse event
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
(1)Patients who are 20 years old or more at the time of consent acquisition.
(2) Patients provided written informed consent
(3)Patients who have been issued prescriptions by medical institutions
Key exclusion criteria
(1)Requested for cancellation from patients
(2)Interrupted due to the circumstances of the research patients (moving, changing doctor / hospital, busy, unfollowable)
(3)Judged that evaluation is not possible due to serious deviation from protocol
(4)Patients judged inappropriate in this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Shimizu |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Pharmacy
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3570-0214
hisanori.shimizu@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Murata |
Organization
Qol Co., Ltd.
Division name
Kanto Pharmacy Headquarter 1
Zip code
224-0032
Address
36-6, Chigasakichuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-5800
Homepage URL
hayato-m@pharm.showa-u.ac.jp
Sponsor or person
Institute
School of Nursing and Rehabilitation Sciences, Showa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Health Labour Sciences Research Grant
Geriatric Oncology Guideline-establishing (GOGGLE) Study Group; Geriatric Oncology Guideline-establishing (GOGGLE) Study
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
(1)QOL Co., Ltd.
(2)Nihon Chouzai Co., Ltd.
(3)KRAFT Inc.
(4)SOGO MEDICAL CO., LTD
(5)AIN PHARMACIEZ INC.
(6)Study group for Comprehensive Cost-Effectiveness Analysis of Pharmacotherapy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Nursing and Rehabilitation Sciences, Showa University
Address
1865, Tokaichibacho, Midori-ku, Yokohama, Kanagawa, Japan
Tel
045-985-6503
nr-rinri@ofc.showa-u.ac.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
(1)クオール株式会社
(2)日本調剤株式会社
(3)クラフト株式会社
(4)総合メディカル株式会社
(5)株式会社アインファーマシーズ
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 30 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
We research health-related QOL with EQ-5D-5L using a web application; prospective observational study.
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047830
