Quality Of LIfe Tool for IBD (QOLITI)
Research type
Research Study
Full title
Quality Of LIfe Tool for IBD (QOLITI): Pilot testing of a self-administered intervention to target psychological distress in Inflammatory Bowel Disease
IRAS ID
181298
Contact name
Lyndsay Hughes
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 10 months, 27 days
Research summary
High levels of distress are common in people with long term conditions including Inflammatory Bowel Disease (IBD). Symptoms can cause fear, embarrassment and be difficult to manage for some people with IBD, particularly at diagnosis. Successful adjustment to and management of IBD is important so that people can achieve good quality of life and clinical outcomes.
IBD clinics are not currently funded to offer psycho-social support to people with IBD to aid adjustment and self-management. An alternative is to promote self-management through self-help manuals. This type of intervention is cheaper and well received with 90% of people indicating that they enjoyed using a similar manual for IBS. This study aims to pilot test a new IBD-specific self-management manual. Each chapter of the manual addresses a different topic with information, guidance in setting goals for behaviour change and accompanying tasks to aid implementation which will be completed at home in the participant’s own time.
A pilot randomised controlled trial will be carried out with sixty people recruited from the IBD clinic at Guy’s and St Thomas’ NHS Foundation Trust. Thirty adults with IBD will be randomised to use the manual for 6-8 weeks (intervention group) and thirty participants will be randomised to receive treatment as usual (control group). Data on consent rate, completion of the manual and changes in depression, anxiety and quality of life approximately 10 weeks after randomisation will be analysed to determine whether those in the intervention group had improved distress and quality of life and if they differed from the control group. At the end of the trial, the control group will be offered the manual. This self-management manual has the potential to be successfully adopted into standard care for IBD.
Furthermore we aim to develop guidelines and a workshop for HCP.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1954
Date of REC Opinion
27 Nov 2015
REC opinion
Favourable Opinion