Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01349504
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2011-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
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:
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
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
Detailed Description:
Specific Aims:
1. To test a novel interview instrument to classify patients into "adherence profiles"
2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
1. To test a novel interview instrument to classify patients into "adherence profiles"
2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.
Study Design Rationale:
Qualitative research design and prospective validation
Study Oversight
Has Oversight DMC:
False
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?: