Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

Ulcerative Colitis Clinical Trial

Official title:

Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120391
• Other study ID #: 2012 - 0726
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.

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-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• At least 18 -65 years of age.

• 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

• Have an iPhone (personal iPhone)

• Patient may receive steroid or mesalamine enemas during the study only on an as needed basis

Exclusion Criteria:

• Are on more than one medication for their inflammatory bowel disease

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• iPhone Application
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence using iPhone App		3 months
Secondary	Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)		3 months