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Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Ulcerative Colitis
Crohn's Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01349504
2011-P-000067/1

Details and patient eligibility

About

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

Full 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

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

106 participants in 1 patient group

Mesalmine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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