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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name