Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

NCT ID: NCT02120391

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-12-31

Brief Summary

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

Detailed 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control (Arm A)

Patients randomized to Arm A(control group) will receive an iPhone application without any of the adherence intervention turned on. The control phone application will allow patients to record their medications and how many refills they have remaining. The application will also provide patients with links about their medication.

No adherence intervention will be done to these patients.

Group Type: SHAM_COMPARATOR

iPhone Application

Intervention Type: OTHER

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

Cases (Arm B)

Patients randomized to Arm B will receive an iPhone application with the adherence intervention turned on. The study coordinator will help with the installation of the iPhone application.

Participants in this group will not need to pay for the iPhone application.

Group Type: EXPERIMENTAL

iPhone Application

Intervention Type: OTHER

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

Interventions

iPhone Application

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Freddy Caldera, DO

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

2012 - 0726

Identifier Type: -

Identifier Source: org_study_id