Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

September 27, 2018 updated by: Heba Iskandar, Emory University

Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease

The purpose of this is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention that will include telephone reminders, educational materials, visits to the physician, and financial counseling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New or existing diagnosis of inflammatory bowel disease (IBD) proven via endoscopy, pathology, and radiology findings
  • Maintained or started on a medication for inflammatory bowel disease at the time of enrollment
  • Ability to speak English
  • Good hearing
  • Phone availability

Exclusion Criteria:

  • Pregnancy or plans to be pregnant
  • Inability to make own health care decisions
  • Inability to participate in the study phone calls
  • Uncontrolled psychiatric illness
  • Enrollment in another clinical trial outside of the standard clinic IBD registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Health-literacy Assessment
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with low adherence will continue to one or more intervention groups that address needs based on the results of the survey.
Experimental: Health-literacy Assessment + Education and Reminders
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with then complete a 24-week intervention aimed to improve education about inflammatory bowel disease and scheduled nurse phone call reminders.
Behavioral: Education and Reminders
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will be provided education materials, and will receive scheduled educational reminder phone calls and text messages at 2,6,12, and 24 weeks from the baseline assessment.
Experimental: Health-literacy Assessment + Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.
Behavioral: Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence.Participants will undergo one scheduled visit with a nurse practitioner or physician for education about inflammatory bowel disease (IBD) after the baseline assessment.
Experimental: Health-literacy Assessment + Medication Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.
Behavioral: Medication Educational Visit
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will undergo one scheduled visit with a nurse practitioner or physician to discuss medication side effects and medication inadequacy after the baseline assessment.
Experimental: Health-literacy Assessment + Financial Support
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.
Behavioral: Financial Support
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will receive information about patient assistance programs, copay cards, and a scheduled meeting with a social worker or financial advisor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Medication Possession Ratio (MPR)
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
The Medication possession Rate (MPR) will be calculated as the amount of medication consumed divided by days in the interval and adherence will be defined as greater than 80%.
12 Weeks, End of Study (Up to 24 weeks)
Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
MMAS-8 is an 8-item scale that has been validated to measure adherence in IBD patients (scoring details are claimed as proprietary information by the scale's copyright holder).
12 Weeks, End of Study (Up to 24 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Harvey Bradshaw Index (HBI) Score
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
The HBI is a self-administered questionnaire that assesses IBD severity. A score of less than 5 is generally considered to represent clinical remission. A score of 8 to 9 or higher are considered severe disease.
12 Weeks, End of Study (Up to 24 weeks)
Change in Simple Colitis Activity Index (SCAI) Score
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
The SCAI is a way of scoring disease activity in Ulcerative Colitis based on six simple questions about symptoms that gives a number between 0-19 that corresponds to the severity of disease activity. This index gives more detailed information on how active disease is using a number.
12 Weeks, End of Study (Up to 24 weeks)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life tool measuring physical, social, and emotional status. Scores range from 10-70. A lower score indicates poor quality of life while a higher score indicates greater quality of life.
12 Weeks, End of Study (Up to 24 weeks)
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale that asks participants to describe how they feel. Scores range between 0 and 21. A score of 0 to 7 is normal. A score of 8 to 10 indicates borderline depression/anxiety. A score of 11-21 indicates a case of depression/anxiety.
12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Admissions
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.
12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Clinic Visits
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.
12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Emergency Visits
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.
12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Surgeries
Time Frame: 12 Weeks, End of Study (Up to 24 weeks)
Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.
12 Weeks, End of Study (Up to 24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heba Iskandar, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00075262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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