UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a Symptom Scale of Gastroesophageal Reflux Disease (GERD)
Title of the study (Brief title)	GERD symptom scale study
Region	Japan

Condition
Condition	Gastroesophageal Reflux Disease (GERD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop a symptom scale by self-assessment questionnaire to assess the improvement of GERD symptoms by proton pump inhibitors
Basic objectives2	Others
Basic objectives -Others	Development of a symptom scale
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reliability/validity/ responsiveness to treatment of the symptom scale for GERD developed in this study
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	I. [Common to Steps 1 to 3] 1. Patients who have been diagnosed with GERD (including reflux esophagitis and non-erosive gastroesophageal reflux disease) during routine medical care and have GERD symptoms 2. Male or female and is aged 20 years or older at the time of informed consent II. [Step 1] Qualitative study (individual or group interview) 3. Patients capable of understanding the questions of the research team member or examiner and those capable of verbally explaining their own symptoms. III. [Steps 2 and 3] 4. Patients with untreated gastroesophageal reflux disease and are planning to undergo treatment with a proton pump inhibitor
Key exclusion criteria	1.Patients strongly suspected of having ischemic heart disease 2.Patients strongly suspected of having asthma or chronic cough 3.Patients with obvious cognitive dysfunction that would affect the research
Target sample size	440

Research contact person
Name of lead principal investigator	Yoshihiro Onishi, pHD.
Organization	Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)
Division name	iHope Research
Address	Kyoto Daiichi Seimei Izumiya Bldg 7F, 513 Akinonocho, Karasuma-dori 2-jo sagaru, Nakagyo-ku, Kyoto, Japan 604-0847
TEL	075-211-5656
Email	onishi@i-hope.jp

Public contact
Name of contact person	Yoshihiro Onishi,phD.
Organization	iHope International
Division name	iHope Research
Address	Kyoto Daiichi Seimei Izumiya Bldg 7F, 513 Akinonocho, Karasuma-dori 2-jo sagaru, Nakagyo-ku, Kyoto,
TEL	075-211-5656
Homepage URL
Email	research@i-hope.jp

Sponsor
Institute	Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)
Institute
Department

Funding Source
Organization	Specified Nonprofit Organization Institute for Health Outcomes & Process Evaluation research (iHope International)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都第一赤十字病院 Japanese Red Cross Kyoto Daiichi Hospital 高槻赤十字病院 Takatsuki Red Cross Hospital 兵庫医科大学病院 The Hospital of Hyogo College of Medicine

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 21 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a multicenter, non-invasive, non-interventional clinical study to develop a GERD symptom scale by the following three steps: Step1 Qualitative study: An anonymous self-assessment questionnaire on GERD symptoms will be completed by GERD patients. In addition, an individual or group interview will be performed under the following themes: Subjective symptoms of GERD, including severity, frequency, and onset condition and the associated obstacles, etc. in daily life, and the past therapeutic effect, change in GERD symptoms after treatment. Subjects remarks will be recorded and organized, and concepts and words representing GERD symptoms will be extracted. Based on these results, a preliminary version of the questionnaire containing a number of items will be prepared. Step2 Pilot study: A different set of GERD patients will be asked to respond to the preliminary version of the questionnaire prepared in the preceding step. They will then be asked for feedback on comprehension of the questionnaire items and ease of answering questions. Responses will be aggregated and their distribution will be confirmed. Based on these results, questionnaire items will be refined and the development version of the questionnaire will be created. Step3 Development study: A completely new [and independent] set of GERD patients will be asked to complete the questionnaire prepared in the preceding step. Item analysis, determination of factor structure, selection of questionnaire items, and assessment of reliability/validity will be performed on the results of the responses taken before treatment. The mean change in the scale scores before and after treatment will be analyzed and assessment of the treatment response will be performed. Based on these results, a symptom scale as a questionnaire consisting of a small number of questionnaire items will be prepared.

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024547