Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatment range of electronic pill dispensers with alarms
Phase phase 3
Sponsor University Hospitals, Leicester
Start date December 2007
End date April 2008
Trial size 80 participants
Trial identifier NCT00398593, REC 06/Q2502/100, UHL 09788

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

Measure
Levels of patient adherence to therapy will be assessed in two ways:
time frame: 1 year
through pill counts and measurement of salicylate levels in urine samples.
time frame: 1 year

Secondary Outcomes

Measure
Quantitative data will be collected through feedback from patients.
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.
Principal investigator John F Mayberry, DScMD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University Hospitals, Leicester.