Clinical trial NCT02620514: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Digestive Disease and Disorders
Inflammation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Medication Possession Ratio (MPR)
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
Secondary outcomes:
measure: Change in Harvey Bradshaw Index (HBI) Score
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Simple Colitis Activity Index (SCAI) Score
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Disease Activity Assessed by the Number of Admissions
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Disease Activity Assessed by the Number of Clinic Visits
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Disease Activity Assessed by the Number of Emergency Visits
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
measure: Change in Disease Activity Assessed by the Number of Surgeries
timeFrame: 12 Weeks, End of Study (Up to 24 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Heba Iskandar, MD
role: PRINCIPAL_INVESTIGATOR
References: