Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

Emory University

Status: Completed

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Behavioral: Education and Reminders; Behavioral: Educational Visit; Behavioral: Medication Educational Visit; Behavioral: Financial Support

Study type: Interventional

Funder types: Other

Identifiers

NCT02620514

IRB00075262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 5 patient groups

Health-literacy Assessment

No Intervention group

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.

Health-literacy Assessment + Education and Reminders

Experimental group

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.

Treatment:

Behavioral: Education and Reminders

Health-literacy Assessment + Educational Visit

Experimental group

Description:

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.

Treatment:

Behavioral: Educational Visit

Health-literacy Assessment + Medication Educational Visit

Experimental group

Description:

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.

Treatment:

Behavioral: Medication Educational Visit

Health-literacy Assessment + Financial Support

Experimental group

Description:

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.

Treatment:

Behavioral: Financial Support