Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

Ulcerative Colitis Clinical Trial

Official title:

Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00398593
• Other study ID #: UHL 09788
• Secondary ID: REC 06/Q2502/100
• Status: Unknown status
• Phase: Phase 3
• First received: November 13, 2006
• Last updated: February 13, 2009
• Start date: December 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• Range of electronic pill dispensers with alarms
Patients will be offered 1. Counselling with education and/or 2. Electronic reminders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of patient adherence to therapy will be assessed in two ways:		1 year
Primary	through pill counts and measurement of salicylate levels in urine samples.		1 year
Secondary	Quantitative data will be collected through feedback from patients.		1 year