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| ID | Type | Description | Link |
|---|---|---|---|
| REC 06/Q2502/100 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Range of electronic pill dispensers with alarms | Behavioral | Patients will be offered 1. Counselling with education and/or 2. Electronic reminders |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative data will be collected through feedback from patients. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John F Mayberry, DScMD | University Hospitals, Leicester | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2009 | |
| Reset | Dec 23, 2009 | |
| Release | Jan 18, 2010 | |
| Reset | Feb 3, 2010 | |
| Release | Mar 23, 2010 | |
| Reset | Apr 23, 2010 | |
| Release | Aug 1, 2012 | |
| Unrelease | Yes | |
| Release | Aug 15, 2012 | |
| Reset | Sep 12, 2012 | |
| Release | Oct 16, 2012 | |
| Reset | Nov 15, 2012 | |
| Release | Dec 3, 2012 | |
| Reset | Jan 2, 2013 | |
| Release | Jan 11, 2013 | |
| Reset | Feb 12, 2013 | |
| Release | Jun 24, 2013 | |
| Reset | Jul 29, 2013 | |
| Release | Apr 27, 2021 | |
| Reset | May 18, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2009 | Dec 23, 2009 | |||
| Jan 18, 2010 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D000099060 | Adherence Interventions |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Feb 3, 2010 |
| Mar 23, 2010 | Apr 23, 2010 |
| Aug 1, 2012 | Yes |
| Aug 15, 2012 | Sep 12, 2012 |
| Oct 16, 2012 | Nov 15, 2012 |
| Dec 3, 2012 | Jan 2, 2013 |
| Jan 11, 2013 | Feb 12, 2013 |
| Jun 24, 2013 | Jul 29, 2013 |
| Apr 27, 2021 | May 18, 2021 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |