Methods of Improvement Adherence With Therapy in Ulcerative Colitis. - Full Text View

Sponsored by:	University Hospitals, Leicester
Information provided by:	University Hospitals, Leicester
ClinicalTrials.gov Identifier:	NCT00398593

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Behavioral: Range of electronic pill dispensers with alarms	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Quantitative data will be collected through feedback from patients.

Estimated Enrollment:	160
Study Start Date:	January 2007

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398593

Contacts

Contact: Tetyana Moshkovska, MD

+44(0)1162588869 ext 8869

tm111@le.ac.uk

Sponsors and Collaborators

University Hospitals, Leicester

Investigators

Principal Investigator:

John F Mayberry, DScMD

University Hospitals, Leicester

More Information

Study ID Numbers:	UHL 09788, REC 06/Q2502/100
Study First Received:	November 13, 2006
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00398593
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals, Leicester:

Adherence with therapy
Adherence enhancing intervention
Nonadherence
Ulcerative colitis

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009