Study name |
A supported online self‐management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD‐BOOST trial |
Methods |
RCT, multicentre |
Participants |
680 adults 18 and above |
Interventions |
IG: facilitator‐supported online self‐management CG: care as usual |
Outcomes |
Primary: UK Inflammatory Bowel Disease Questionnaire (UK‐IBDQ) and global rating of symptom relief at 6 months after randomisation Secondary:
UK‐IBDQ at 12 months
Rating of satisfaction with results of BOOST programme (simple 0‐to‐100 VAS) at 6 and 12 months only
Global rating of symptom relief at 12 months
Numerical (0 to 10) pain rating scale at baseline, 6 and 12 months after randomisation
Vaizey (faecal) incontinence score, reflecting participants’ perceptions of severity at baseline, 6 and 12 months after randomisation
IBD‐Fatigue score at baseline, 6 and 12 months after randomisation
IBD‐Control score; 8‐item self‐reported score to measure disease control from the participant's perspective at baseline, 6 and 12 months after randomisation
EQ‐5D‐5L general health‐related quality of life at baseline and 6 and 12 months after randomisation
|
Starting date |
1 October 2019 |
Contact information |
christine.norton@kcl.ac.uk jonathan.syred@kcl.ac.uk |
Notes |
Sponsor: London North West University Healthcare NHS Trust |