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Completed

NCT Number: NCT02120391

Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iPhone Application

Other

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

Primary outcomes

  1. Medication adherence using iPhone App

    Time frame: 3 months

Secondary outcomes

  1. Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2014
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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