A Phase 3 interventional study of Range of electronic pill dispensers with alarms in Ulcerative Colitis, sponsored by University Hospitals, Leicester. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-02-16.
Sponsored by University Hospitals, Leicester · Phase 3, Interventional, and Supportive care
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →University Hospitals, Leicester is the lead sponsor of 67 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
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
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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University Hospitals, Leicester