Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.
2 other identifiers
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2007
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFebruary 16, 2009
February 1, 2009
4 months
November 13, 2006
February 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Levels of patient adherence to therapy will be assessed in two ways:
1 year
through pill counts and measurement of salicylate levels in urine samples.
1 year
Secondary Outcomes (1)
Quantitative data will be collected through feedback from patients.
1 year
Interventions
Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John F Mayberry, DScMD
University Hospitals, Leicester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2006
First Posted
November 14, 2006
Study Start
December 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2009
Last Updated
February 16, 2009
Record last verified: 2009-02