Recruitment

Recruitment Status
Completed
Estimated Enrollment
99

Inclusion Criterias

At least 18 -65 years of age.
Have an iPhone (personal iPhone)
Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
...
At least 18 -65 years of age.
Have an iPhone (personal iPhone)
Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
On a stable dose of mesalamine for at least two months prior to entering the study
Patient may receive steroid or mesalamine enemas during the study only on an as needed basis

Summary

Conditions
Ulcerative Colitis
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-ad...

Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-adherence in patients in clinical remission is high with rates around 60%. Non adherence in patients in clinical remission can have significant impact because it can lead to higher rates of clinical flares and increased health care cost. This will be a single-blinded randomized controlled trial to evaluate if patients randomized to an iPphone application vs. control can increase the adherence of their maintenance medication. The trial will last three months and we hope to enroll 99 patients. The primary outcome will be adherence measured by the medication possession ratio. The secondary objective will be to evaluate if a validated adherence questionnaire can predict adherence in patients with inflammatory bowel disease. Having an intervention that can increase adherence can provide better care for patients. Also having a validated survey tool can accurately identify non-adherence in inflammatory bowel disease patient would be a valuable tool for patient care.

Inclusion Criterias

At least 18 -65 years of age.
Have an iPhone (personal iPhone)
Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
...
At least 18 -65 years of age.
Have an iPhone (personal iPhone)
Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
On a stable dose of mesalamine for at least two months prior to entering the study
Patient may receive steroid or mesalamine enemas during the study only on an as needed basis

Locations

Madison, Wisconsin, 53792
Madison, Wisconsin, 53792

Tracking Information

NCT #
NCT02120391
Collaborators
Not Provided
Investigators
  • Principal Investigator: Freddy Caldera, DO University of Wisconsin, Madison
  • Freddy Caldera, DO University of Wisconsin, Madison