Ulcerative ColitisNCT01678300
Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
An observational study of Ulcerative Colitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this protocol is: 1. To quantify the prevalence of adherence to topical mesalamine in patients with UC 2. To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2015
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will be adults with diagnosed Ulcerative Colitis who have been prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.
Who may be able to join
- must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation
- must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor
- must be receiving care at Beth Israel Deaconess Medical Center
Who cannot join
- no diagnosis of ulcerative colitis
- no prescription for topical mesalamine
- not receiving care at Beth Israel Deaconess Medical Center
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this protocol is:
- To quantify the prevalence of adherence to topical mesalamine in patients with UC
- To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine
Read the detailed description
Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.
The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
Measured: 12 months
Secondary outcomes (3)
Clinical outcome (remission / relapse) at 12 months grouped by persistence status
Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score
Measured: 12 months
Adherence phenotype details
- Prevalence of self-reported "low adherence" amongst patients prescribed topical mesalamine
- Demographic and disease phenotype variables associated with "non persistence" or "low adherence" using multivariate logistic regression analysis
Measured: 12 months
Quality-of-life score at 12 months
Short Inflammatory Bowel Disease Questionnaire score at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
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 Beth Israel Deaconess Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan C. Moss, Beth Israel Deaconess Medical Center
- Investigators
- Alan C Moss, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678300
- Sponsor's protocol ID
- 2012-P-000100
- Status last verified
- Nov 2015
- First submitted
- 23 Aug 2012
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)
- ClinicalTrials.gov ID
- NCT01678300
- Acronym / sponsor ID
- 2012-P-000100
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Sep 2012 (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 protocol is:
- To quantify the prevalence of adherence to topical mesalamine in patients with UC
- To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine
Detailed description
Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.
The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be adults with diagnosed Ulcerative Colitis who have been prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.
Key inclusion criteria (3 listed)
- must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation
- must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor
- must be receiving care at Beth Israel Deaconess Medical Center
Key exclusion criteria (3 listed)
- no diagnosis of ulcerative colitis
- no prescription for topical mesalamine
- not receiving care at Beth Israel Deaconess Medical Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
Time frame: 12 months
3 secondary outcomes
Clinical outcome (remission / relapse) at 12 months grouped by persistence status
Time frame: 12 months
Adherence phenotype details
Time frame: 12 months
Quality-of-life score at 12 months
Time frame: 12 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 16 Nov 2015.
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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.
Alan C Moss, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Beth Israel Deaconess Medical Center 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 3 inclusion and 3 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 16 Nov 2015. 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. 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?
Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC (time frame: 12 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 16 Nov 2015.