Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

November 26, 2018 updated by: University of Wisconsin, Madison
The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication adherence using iPhone App
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Freddy Caldera, DO, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012 - 0726

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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