Patient outcomes in ulcerative colitis
Research type
Research Study
Full title
Monitoring Patient-Reported 6-point Mayo Scores, Quality of Life and Work Productivity in Golimumab Treated Ulcerative Colitis Patients Over Time.
IRAS ID
211719
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
Merck
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
There is current interest in developing web portals and mobile phone applications that may be used in future to help doctors monitor disease activity in their patients. In this study, we will look at the feasibility of collecting online data from patients. Eligible patients will be those who have ulcerative colitis and are being treated with golimumab. Patients will be asked to provide “PRO 2 Mayo scores” once per month for 6 months by entering online data via their phone, tablet or computer. The PRO2 Mayo score has been used in previous research and requires that patients answer two questions about their condition on rectal bleeding and stool frequency. We will also ask patients to complete additional questionnaires at the start and at the end of the study looking at quality of life and any loss of work or leisure time (work productivity). Finally, at the end of the study, we will ask patients their thoughts/ feelings about the process of providing PRO 2 Mayo scores on a regular basis. The data will provide information on whether this could be a useful way of regularly monitoring some ulcerative colitis patients in future which might provide better disease control without frequent hospital appointments or invasive procedures.
For the purpose of this study, this data will be anonymized and will not be reviewed by the patient’s healthcare team. However, the treating doctor will be asked to provide some key data from the patient’s medical records (e.g. treatment information).
To conduct this research, there will be approximately 30 participating UK hospitals and they will invite patients to volunteer to take part. Patients will be involved in the study for 6 – 7 months.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1880
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion