Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

Ulcerative Colitis Clinical Trial

Official title:

Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620514
• Other study ID #: IRB00075262
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: September 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	12 Weeks, End of Study (Up to 24 weeks)
Primary	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).	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)
Secondary	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.	12 Weeks, End of Study (Up to 24 weeks)