Methods of Improvement Adherence With Therapy in Ulcerative Colitis.

Patient Adherence to Prescribed Therapy in Ulcerative Colitis: an Investigation of Barriers & Methods of Improvement.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398593

Enrollment

Registered

2006-11-14

Start date

2007-12-31

Completion date

2009-04-30

Last updated

2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Adherence with therapy, Adherence enhancing intervention, Nonadherence, Ulcerative colitis

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.

Interventions

BEHAVIORALRange of electronic pill dispensers with alarms

Patients will be offered 1. Counselling with education and/or 2. Electronic reminders

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Quantitative data will be collected through feedback from patients.	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026