Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398593
Recruitment Status : Unknown
Verified February 2009 by University Hospitals, Leicester.
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2006
Last Update Posted : February 16, 2009
Information provided by:
University Hospitals, Leicester

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Behavioral: Range of electronic pill dispensers with alarms Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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.
Study Start Date : December 2007
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Levels of patient adherence to therapy will be assessed in two ways: [ Time Frame: 1 year ]
  2. through pill counts and measurement of salicylate levels in urine samples. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quantitative data will be collected through feedback from patients. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398593

Sponsors and Collaborators
University Hospitals, Leicester
Principal Investigator: John F Mayberry, DScMD University Hospitals, Leicester

Responsible Party: Carolyn Burden, Leicester General Hospital Identifier: NCT00398593     History of Changes
Other Study ID Numbers: UHL 09788
REC 06/Q2502/100
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University Hospitals, Leicester:
Adherence with therapy
Adherence enhancing intervention
Ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases