UMIN-CTR Clinical Trial

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
Institute	EA Pharma Co.,Ltd.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047583