Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Alan C. Moss, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01349504
First received: April 25, 2011
Last updated: February 27, 2012
Last verified: February 2012
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Purpose
Hypothesis:
Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.
Objectives:
To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence
| Condition |
|---|
|
Ulcerative Colitis Crohn's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease |
Resource links provided by NLM:
Further study details as provided by Beth Israel Deaconess Medical Center:
Primary Outcome Measures:
- Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data [ Time Frame: 12 months ] [ Designated as safety issue: No ]Participant's adherence behaviour will be measured using a behavioral profile questionnaire, and both the total score, and each individual sub-score, correlated with medication adherence as measured using pharmacy refill rates
Secondary Outcome Measures:
- Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Validated measure of reported medication adherence
- Spot Urinary 5-ASA [ Time Frame: 12 months ] [ Designated as safety issue: No ]Urine salicylic acid and 5-ASA levels will be measured in participants
- Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]Validated measure of Quality-of-Life for patients with IBD
- Pharmacy Refill Rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mesalamine refill rates will be captured from patiernts' pharmacies
Biospecimen Retention: Samples Without DNA
Urine
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Mesalmine |
Detailed Description:
Specific Aims:
- To test a novel interview instrument to classify patients into "adherence profiles"
- To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients taking mesalamine for maintenance of remission of ulcerative colitis
Criteria
Inclusion Criteria:
- Adult patient (age >18)
- Diagnosis of IBD (confirmed by endoscopy and histology) > 3 months
- In clinical remission (based on Simple Colitis Activity Index score <2.5)
- On mesalamine compound for maintenance of remission
- Stable mesalamine dose for 1 month
Exclusion Criteria:
- Not receiving primary GI care at BIDMC
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349504
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Shire Development LLC
Investigators
| Principal Investigator: | Alan Moss, MD | Beth Israel Deaconess Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alan C. Moss, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01349504 History of Changes |
| Other Study ID Numbers: | 2011-P-000067/1 |
| Study First Received: | April 25, 2011 |
| Last Updated: | February 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013