Clinical trial NCT00398593: Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Official title: Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Adherence with therapy
Adherence enhancing intervention
Nonadherence
Ulcerative colitis
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Levels of patient adherence to therapy will be assessed in two ways:
timeFrame: 1 year
measure: through pill counts and measurement of salicylate levels in urine samples.
timeFrame: 1 year
Secondary outcomes:
measure: Quantitative data will be collected through feedback from patients.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals, Leicester
name: John F Mayberry, DScMD
role: PRINCIPAL_INVESTIGATOR
References: