Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

NCT ID: NCT00398593

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-04-30

Brief Summary

Ulcerative Colitis is associated with a significantly increased risk of colorectal cancer. This risk can be reduced through regular medication with 5ASA compounds. Their effectiveness however is limited by poor adherence to the treatment protocols by many patients.

The hypothesis which underlies this proposal is that if the factors responsible for poor compliance can be identified, interventions could be developed which would help to overcome the barriers which exist in individual patients. These interventions would be based on the reasons for non-adherence, specifically tailored to the needs of the individual. As a result such interventions will improve patients' adherence with prescribed 5ASA and therefore reduce the relapses of the disease and a cancer risk.

Detailed Description

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 interventions.

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Range of electronic pill dispensers with alarms

Patients will be offered 1. Counselling with education and/or 2. Electronic reminders

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 consent.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: lead

Responsible Party

Leicester General Hospital

Principal Investigators

John F Mayberry, DScMD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

References

Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type: DERIVED

PMID: 40243391 (View on PubMed)

Other Identifiers

REC 06/Q2502/100

Identifier Type: -

Identifier Source: secondary_id

UHL 09788

Identifier Type: -

Identifier Source: org_study_id