Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)
- Conditions
- Crohn's DiseaseInflammatory Bowel DiseaseUlcerative Colitis
- Interventions
- Behavioral: Educational VisitBehavioral: Medication Educational VisitBehavioral: Education and RemindersBehavioral: Financial Support
- Registration Number
- NCT02620514
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health-literacy Assessment + Educational Visit Educational Visit Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD. Health-literacy Assessment + Medication Educational Visit 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. Health-literacy Assessment + Education and Reminders 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. Health-literacy Assessment + Financial Support 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.
- Primary Outcome Measures
Name Time Method Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score 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).
Change in Medication Possession Ratio (MPR) 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%.
- Secondary Outcome Measures
Name Time Method Change in Harvey Bradshaw Index (HBI) Score 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.
Change in Simple Colitis Activity Index (SCAI) Score 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.
Change in Hospital Anxiety and Depression Scale (HADS) Score 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.
Change in Disease Activity Assessed by the Number of Clinic Visits 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.
Change in Disease Activity Assessed by the Number of Emergency Visits 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.
Change in Disease Activity Assessed by the Number of Surgeries 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.
Change in Disease Activity Assessed by the Number of Admissions 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.
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score 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.
Trial Locations
- Locations (1)
The Emory Clinic
🇺🇸Atlanta, Georgia, United States