Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Digestive Disease and Disorders, Inflammation
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.
Interventions
BEHAVIORALEducation 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.
BEHAVIORALEducational 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.
BEHAVIORALMedication 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.
BEHAVIORALFinancial 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.
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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 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. |
Countries
United States
Outcome results
None listed