Back to resultsMedication Adherence in Patients With Inflammatory Bowel Disease (IBD)
Primary Purpose
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and Reminders
Educational Visit
Medication Educational Visit
Financial Support
Sponsored by
About this trial
This is an interventional other trial for Inflammatory Bowel Disease focused on measuring Digestive Disease and Disorders, Inflammation
Eligibility Criteria
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
Sites / Locations
- The Emory Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
Health-literacy Assessment
Health-literacy Assessment + Education and Reminders
Health-literacy Assessment + Educational Visit
Health-literacy Assessment + Medication Educational Visit
Health-literacy Assessment + Financial Support
Arm Description
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.
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.
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.
Outcomes
Primary Outcome Measures
Change in Medication Possession Ratio (MPR)
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%.
Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
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).
Secondary Outcome Measures
Change in Harvey Bradshaw Index (HBI) Score
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.
Change in Simple Colitis Activity Index (SCAI) Score
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.
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
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.
Change in Hospital Anxiety and Depression Scale (HADS) Score
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.
Change in Disease Activity Assessed by the Number of Admissions
Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.
Change in Disease Activity Assessed by the Number of Clinic Visits
Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.
Change in Disease Activity Assessed by the Number of Emergency Visits
Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.
Change in Disease Activity Assessed by the Number of Surgeries
Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02620514
Brief Title
Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)
Official Title
Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Keywords
Digestive Disease and Disorders, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health-literacy Assessment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Health-literacy Assessment + Education and Reminders
Arm Type
Experimental
Arm Description
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.
Arm Title
Health-literacy Assessment + Educational Visit
Arm Type
Experimental
Arm Description
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.
Arm Title
Health-literacy Assessment + Medication Educational Visit
Arm Type
Experimental
Arm Description
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.
Arm Title
Health-literacy Assessment + Financial Support
Arm Type
Experimental
Arm Description
Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.
Intervention Type
Behavioral
Intervention Name(s)
Education and Reminders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Visit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Educational Visit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Medication Possession Ratio (MPR)
Description
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%.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
Description
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).
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Secondary Outcome Measure Information:
Title
Change in Harvey Bradshaw Index (HBI) Score
Description
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.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Simple Colitis Activity Index (SCAI) Score
Description
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.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Description
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.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Hospital Anxiety and Depression Scale (HADS) Score
Description
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.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Disease Activity Assessed by the Number of Admissions
Description
Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Disease Activity Assessed by the Number of Clinic Visits
Description
Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Disease Activity Assessed by the Number of Emergency Visits
Description
Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
Title
Change in Disease Activity Assessed by the Number of Surgeries
Description
Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.
Time Frame
12 Weeks, End of Study (Up to 24 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Iskandar, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)
We'll reach out to this number within 24 hrs