Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
1 other identifier
interventional
39
1 country
1
Brief Summary
The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 27, 2018
November 1, 2018
3.3 years
April 14, 2014
November 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Medication adherence using iPhone App
3 months
Secondary Outcomes (1)
Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
3 months
Study Arms (2)
Control (Arm A)
SHAM COMPARATORPatients 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.
Cases (Arm B)
EXPERIMENTALPatients 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.
Interventions
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Are on more than one medication for their inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Freddy Caldera, DO
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 22, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
November 27, 2018
Record last verified: 2018-11