Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Recruitment status was: Active, not recruiting
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.
|Ulcerative Colitis||Behavioral: Range of electronic pill dispensers with alarms||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.|
- 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 ]
- Quantitative data will be collected through feedback from patients. [ Time Frame: 1 year ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||April 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Behavioral: Range of electronic pill dispensers with alarms
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398593
|Principal Investigator:||John F Mayberry, DScMD||University Hospitals, Leicester|