Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Range of electronic pill dispensers with alarms
Sponsored by
About this trial
This is an interventional supportive care trial for Ulcerative Colitis focused on measuring Adherence with therapy, Adherence enhancing intervention, Nonadherence, Ulcerative colitis
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00398593
First Posted
November 13, 2006
Last Updated
February 13, 2009
Sponsor
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT00398593
Brief Title
Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Official Title
Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals, Leicester
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Adherence with therapy, Adherence enhancing intervention, Nonadherence, Ulcerative colitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Range of electronic pill dispensers with alarms
Intervention Description
Patients will be offered 1. Counselling with education and/or 2. Electronic reminders
Primary Outcome Measure Information:
Title
Levels of patient adherence to therapy will be assessed in two ways:
Time Frame
1 year
Title
through pill counts and measurement of salicylate levels in urine samples.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quantitative data will be collected through feedback from patients.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Mayberry, DScMD
Organizational Affiliation
University Hospitals, Leicester
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
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