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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
University Hospitals, Leicester
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 13, 2006
    Last Updated
    February 13, 2009
    Sponsor
    University Hospitals, Leicester
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    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

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