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Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospitals, Leicester.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398593
First Posted: November 14, 2006
Last Update Posted: October 12, 2017
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.
Information provided by:
University Hospitals, Leicester
  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
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.

Resource links provided by NLM:


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 ]
  • through pill counts and measurement of salicylate levels in urine samples. [ Time Frame: 1 year ]

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

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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00398593


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

Responsible Party: Carolyn Burden, Leicester General Hospital
ClinicalTrials.gov Identifier: NCT00398593     History of Changes
Other Study ID Numbers: UHL 09788
REC 06/Q2502/100
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: October 12, 2017
Last Verified: February 2009

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

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