Ulcerative ColitisNCT02120391
Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
A study testing iPhone Application in people with Ulcerative Colitis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- iPhone Application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Are on more than one medication for their inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- iPhone Application
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPhone ApplicationOther
All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
| Study group | Role | What they receive |
|---|---|---|
| Control (Arm A) | Sham comparator | 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. Receives: Other: iPhone Application |
| Cases (Arm B) | Experimental | 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. Receives: Other: iPhone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence using iPhone App
Measured: 3 months
Secondary outcomes (1)
Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120391
- Sponsor's protocol ID
- 2012 - 0726
- Status last verified
- Nov 2018
- First submitted
- 14 Apr 2014
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application
- ClinicalTrials.gov ID
- NCT02120391
- Acronym / sponsor ID
- 2012 - 0726
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Arm A) | Sham comparator | Other: iPhone ApplicationPatients 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) | Experimental | Other: iPhone ApplicationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Are on more than one medication for their inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPhone ApplicationAll subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on. | Other | Cases (Arm B), Control (Arm A) |
Primary outcome
Medication adherence using iPhone App
Time frame: 3 months
1 secondary outcome
Prediction of adherence using self-administered Brief Medication Questionnaire (BMQ)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Caldera, DO principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPhone Application in people with Ulcerative Colitis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence using iPhone App (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018; AzTrials last refreshed its copy on 5 Nov 2026.