Feasibility and usability of the I-GERQ-DD in an electronic format
Research type
Research Study
Full title
Feasibility and usability of the Infant Gastro Esophageal Reflux Questionnaire - Daily Diary in an electronic format
IRAS ID
221905
Contact name
Sophi Tatlock
Contact email
Sponsor organisation
Reckitt Benckiser
Clinicaltrials.gov Identifier
15/WA/0375, REC reference for previous study; 186292, R&D reference for previous study
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
RB is planning to conduct a clinical study to evaluate the safety and efficacy of a new product for the initial management of GOR/GORD in infants and children form 1-24 months. A study previously conducted (RB7253A; WA/15/0375; 186292) identified the Infant Gastroesophageal Reflux Questionnaire Daily Diary (I-GERQ-DD) as a suitable measure of the observable symptoms/signs of Gastroesophageal Reflux (GOR) and Gastroesophageal Reflux Disease (GORD) for inclusion an upcoming trial. Given the I-GERQ-DD was originally designed to be completed daily by parents/caregivers on paper, this study is designed to explore the usability and feasibility of parents/caregivers completing the questionnaire via electronic administration on a mobile platform (e.g. phone or tablet). A sample of parents/caregivers (n=50) will complete the electronic I-GERQ-DD daily for 7-8 days using a smartphone app and/or a web-based platform. On the final day of the study, the parent/caregiver will also complete a paper version of the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R), an earlier version of the I-GERQ-DD, designed to be completed weekly. A small subset of parents/caregivers (n=10) will answer some brief questions about their experiences of completing the electronic diary on a daily basis and whether any issues were encountered which could be improved. The quantitative data collected during this study will be subject to statistical analysis at a later stage, while the qualitative data will be subject to thematic analysis.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0136
Date of REC Opinion
13 Apr 2017
REC opinion
Favourable Opinion