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Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

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ClinicalTrials.gov Identifier: NCT02120391
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: iPhone Application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Medication adherence using iPhone App [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120391


Locations
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United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Freddy Caldera, DO University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02120391    
Other Study ID Numbers: 2012 - 0726
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases