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Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Ulcerative Colitis

Study type

Observational

Funder types

Other

Identifiers

NCT01678300
2012-P-000100

Details and patient eligibility

About

The purpose of this protocol is:

  1. To quantify the prevalence of adherence to topical mesalamine in patients with UC
  2. To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine

Full description

Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.

The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation
  • must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor
  • must be receiving care at Beth Israel Deaconess Medical Center

Exclusion criteria

  • no diagnosis of ulcerative colitis
  • no prescription for topical mesalamine
  • not receiving care at Beth Israel Deaconess Medical Center

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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