Ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged over 16 years with a diagnosis of ulcerative colitis (histologically proven), whose disease has been present for at least one year and who are found, from prescribing records, to be taking aminosalicylate (ASA) therapy at suboptimal levels (defined as using anything less than 8 months supply of aminosalicylates in a 12 month period). Patients who have been specifically told to stop taking their 5ASA medication will be screened out at the stage of initial patient invitation. Eligible patients who subsequently undergo total colectomy and therefore no longer require 5ASA therapy will no longer be eligible for inclusion in the study and will be classified as 'drop-out'.
Exclusion criteria
Exclusion criteria: Patients with self-limiting colitis or those whose UC has been diagnosed in the past year will be excluded. Patients aged less than 16 years are not eligible for inclusion and patients with significant neurological impairment such that they could not participate in the consultation will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in the subject and control groups for whom an increase in adherence with medication is observed. Adherence will be calculated as the percentage of dispensed medications that have been used with adherence defined as taking more than 4 months supply in 6-month period. Adherence therefore is measured as a dichotomous variable (adherent yes/no). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in IBD-specific quality of life, disease activity and relapse rates in both subject and control groups throughout the 6-month follow-up period. Additional explanatory variables are: illness perception (IPQ-R), beliefs about medicines (BMQ), self reported medication adherence, preferred role in the decision making process (Degner) and the demographic variables previously outlined. | — |
Countries
United Kingdom