Methods of Improvement Adherence With Therapy in Ulcerative Colitis.
Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Levels of patient adherence to therapy will be assessed in two ways:
기간: 1 year
|
1 year
|
|
through pill counts and measurement of salicylate levels in urine samples.
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Quantitative data will be collected through feedback from patients.
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: John F Mayberry, DScMD, University Hospitals, Leicester
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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