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Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPhone Application
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Hospital & Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control (Arm A)

Cases (Arm B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Medication adherence using iPhone App

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2014
Last Updated
November 26, 2018
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02120391
Brief Title
Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Official Title
Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (Arm A)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Cases (Arm B)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
iPhone Application
Intervention Description
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
Primary Outcome Measure Information:
Title
Medication adherence using iPhone App
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freddy Caldera, DO
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

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