UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041705 |
|---|---|
| Receipt number | R000047583 |
| Scientific Title | A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2021/03/12 15:58:37 |
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Basic information
Public title
A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Acronym
A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Scientific Title
A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Scientific Title:Acronym
A survey of the impact of COVID-19 on the prescription and other conditions of patients with gastrointestinal diseases
Region
| Japan |
Condition
Condition
gastrointestinal ulcer, reflux esophagitis, chronic constipation, ulcerative colitis , Crohn's disease, and hepatic cirrhosis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of COVID-19 on the prescription, the disease condition, the quality of life and lifestyles of patients with gastrointestinal diseases.
Basic objectives2
Others
Basic objectives -Others
To clarify the impact of COVID-19 on the prescription, the disease condition, the quality of life and lifestyles of patients with gastrointestinal diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The interval, amount, and days of prescriptions for medications of gastrointestinal diseases
Key secondary outcomes
EQ-5D
J-HLS-EU-Q47
Adherence scale for patients with chronic disease
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients registered with Medilead Healthcare Panel (MHP) who have answers at the survey on December 2019 (past survey)
2. Patients who reported in- or outpatient visits for gastrointestinal diseases within 1 year before the past survey
3. Patients who reported gastrointestinal diseases (gastrointestinal ulcer, reflux esophagitis, chronic constipation, ulcerative colitis , Crohn's disease, and hepatic cirrhosis)
Key exclusion criteria
1. Patients who did not report any use of drugs for gastrointestinal diseases at the past survey
2. Patients who reported any cancer at the past survey
3. Patients who work for any of the following organizations
- market research companies
- media companies
- advertising companies
- hospitals or clinics
- pharmaceutical companies
- pharmaceutical wholesalers
4. Patients whose family members work for any of the above organizations
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Masaki |
Organization
EA Pharma Co.,Ltd.
Division name
Medical Division
Zip code
104-0042
Address
Sumitomo-Irifune building, 2-1-1, Irifune, Chuo-Ku, Tokyo, JAPAN
TEL
03-6280-9500
hisanori_masaki@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Masaki |
Organization
EA Pharma Co.,Ltd.
Division name
Medical Division
Zip code
104-0042
Address
Sumitomo-Irifune building, 2-1-1, Irifune, Chuo-Ku, Tokyo, JAPAN
TEL
03-6280-9500
Homepage URL
hisanori_masaki@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
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
Yamauchi clinic
Address
1-15-19, Jiyugaoka, Meguro-Ku, Tokyo, Japan
Tel
03-5575-5862
Not Appricable
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
| 2020 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/49010/17
Number of participants that the trial has enrolled
650
Results
About 20% of eligible patients reduced their
visit and 70% of them had not restored the f
requency of visits. Their symptoms changed m
ore widely than those who not. We identified
longer duration of disease and higher medica
l adherence score as the factors not reducin
g visits. Few patients used telemedicine. A
quarter of patients were recording their sy
mptoms and they had higher medical adherence
score.
Results date posted
| 2021 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 28 | Day |
Baseline Characteristics
In 650 participants, 396(60.9%) were male an
d 254(39.1%) were female.
The number of participants who had reflux es
ophagitis, chronic constipation, ulcerative
colitis, Crohn's disease, gastrointestinal
ulcer and hepatic cirrhosis were 202(31.
1%), 182(28.0%), 165(25.4%). 52(8.0%), 40(6.
2%), 9(1.4%), respectively.
Participant flow
We used the Medilead Healthcare Panel, one o
f the largest Japanese survey database, and
identified 5260 patients with gastrointesti
nal diseases age of over 20 and having in- o
utpatient visit within a year before the sur
vey conducted on October 2019. We conducted
a web survey of them on September 2020. Of
5260, 3475 answered the survey and 650 of t
hem expressed consent on web form and were e
nrolled the study.
Adverse events
N/A
Outcome measures
EQ-5D was improved compared with the survey
conducted on December 2019 (past survey). F
urthermore, participants who did not refrain
from visiting hospital showed significantly
higher EQ-5D than those who did (p=0.001)
Medical adherence scale and J-HLS-EU-Q47 wer
e not significantly different between this s
urvey and past survey.
Plan to share IPD
N/A
IPD sharing Plan description
N/A
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 23 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
A web-based survey on patients registered with Medilead Healthcare Panel (MHP) and meet all eligible criteria.
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047583
