Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398593
Status:
UNKNOWN
Last Update Posted:
2009-02-16
First Post:
2006-11-13
Brief Title:
Methods of Improvement Adherence With Therapy in Ulcerative Colitis
Sponsor:
University Hospitals Leicester
Organization:
University Hospitals Leicester
Study Overview
Official Title:
Patient Adherence to Prescribed Therapy in Ulcerative Colitis an Investigation of Barriers Methods of Improvement
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REC 06Q2502100 | None | None | None |