Inflammatory Bowel Disease (IBD) Clinical Trial
Official title:
A Pilot Randomised Controlled Trial to Determine the Feasibility, Acceptability and Effectiveness of a CBT Based Online Intervention to Address Practical and Perceptual Barriers to Medication Adherence in Inflammatory Bowel Disease.
Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing
inflammatory conditions that usually affect the colon and the small intestine. Between 30 to
45% of patients with IBD do not take their treatment as prescribed by their health care team
(Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA)
provides a theoretical framework to develop adherence interventions that are patient-centred
(Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the
medication but there are barriers beyond their control, such as not understanding the
instructions (practical barriers). Intentional non-adherence is the result of the beliefs
affecting the patient's motivation to continue with treatment (perceptual barriers).
Aims
1. To develop an internet-based intervention to address perceptual and practical barriers
to adherence to medicine for IBD.
2. To determine whether the intervention is effective based on change in both types of
barriers.
Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD;
currently prescribed azathioprine, mesalazine, and/or adalimumab.
240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will
take part in the study. An online pilot Randomised Controlled Trial will allocate the
participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or
Treatment as Usual group. On first visiting the website, participants will be screened for
eligibility and asked for consent before answering the questionnaires. The website will
assign intervention modules to be completed based on an individual's profile.
Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month
follow-ups.
Potential Impact A CBT based online intervention tailored to personal needs and concerns may
benefit a large number of patients with low costs for the national healthcare services. A
website can be accessed at a time and place convenient to the patient.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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