Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01349504

Enrollment

106

Registered

2011-05-06

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2013-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data	12 months	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

Measure	Time frame	Description
Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6)	12 months	Validated measure of reported medication adherence
Spot Urinary 5-ASA	12 months	Urine salicylic acid and 5-ASA levels will be measured in participants
Short Inflammatory Bowel Disease Questionnaire	12 months	Validated measure of Quality-of-Life for patients with IBD
Pharmacy Refill Rates	12 months	Mesalamine refill rates will be captured from patiernts' pharmacies

Countries

United States

Outcome results