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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

77

Phase

  • 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

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
Intervention / Treatment
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

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

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

Emory University

Investigators

  • 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)

June 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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