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Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Phase 3
18 Years
80 Years
Open (Enrolling)
Ulcerative Colitis

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Trial Information

Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Poor adherence to treatment is well recognised and significantly contributes to treatment
failures. In ulcerative colitis it may be associated with an increased risk of colorectal
cancer. Estimates for non-adherence range from 15% to 93% with an average of around a third
of patients failing to adhere to their recommended therapeutic regimen.

The study aims to evaluate a wide-ranging approach to reducing poor adherence, which is
based on factors associated with non-adherence and involves the patient in choosing

The effectiveness of the overall intervention will be assessed through a randomised
controlled trial comparing intervention against standard care.

Inclusion Criteria:

- Male and female patients aged 18-80.

- Those in whom a diagnosis of ulcerative colitis is based on histological confirmation
of the disease.

- Patients who are on daily maintenance therapy with 5 ASA medication.

- Patients who have read the information leaflet and voluntarily given informed

Exclusion Criteria:

- Those aged under 18 years old.

- Those with a diagnosis of Crohn's disease.

- Patients not on regular 5ASA compound as maintenance therapy.

- Patients unable to give informed consent.

- Patients who do not wish to participate in the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Levels of patient adherence to therapy will be assessed in two ways:

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

John F Mayberry, DScMD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals, Leicester


United Kingdom: Research Ethics Committee

Study ID:

UHL 09788



Start Date:

December 2007

Completion Date:

April 2009

Related Keywords:

  • Ulcerative Colitis
  • Adherence with therapy
  • Adherence enhancing intervention
  • Nonadherence
  • Ulcerative colitis
  • Colitis
  • Colitis, Ulcerative
  • Ulcer