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Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospitals, Leicester.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00398593
First received: November 13, 2006
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Levels of patient adherence to therapy will be assessed in two ways: [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • through pill counts and measurement of salicylate levels in urine samples. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantitative data will be collected through feedback from patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2007
Estimated Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Range of electronic pill dispensers with alarms
    Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
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

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

No publications provided

Responsible Party: Carolyn Burden, Leicester General Hospital
ClinicalTrials.gov Identifier: NCT00398593     History of Changes
Other Study ID Numbers: UHL 09788, REC 06/Q2502/100
Study First Received: November 13, 2006
Last Updated: February 13, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013