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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01349504
Other study ID # 2011-P-000067/1
Secondary ID
Status Completed
Phase N/A
First received April 25, 2011
Last updated August 16, 2013
Start date April 2011
Est. completion date December 2012

Study information

Verified date August 2013
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Shire

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data 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 12 months No
Secondary Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) Validated measure of reported medication adherence 12 months No
Secondary Spot Urinary 5-ASA Urine salicylic acid and 5-ASA levels will be measured in participants 12 months No
Secondary Short Inflammatory Bowel Disease Questionnaire Validated measure of Quality-of-Life for patients with IBD 12 months No
Secondary Pharmacy Refill Rates Mesalamine refill rates will be captured from patiernts' pharmacies 12 months No
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