Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

NCT ID: NCT02620514

Last Updated: 2018-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-01

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Health-literacy Assessment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Health-literacy Assessment + 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.

Group Type EXPERIMENTAL

Education and Reminders

Intervention Type BEHAVIORAL

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.

Health-literacy Assessment + Educational Visit

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

Group Type EXPERIMENTAL

Educational Visit

Intervention Type BEHAVIORAL

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.

Health-literacy Assessment + 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.

Group Type EXPERIMENTAL

Medication Educational Visit

Intervention Type BEHAVIORAL

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.

Health-literacy Assessment + 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.

Group Type EXPERIMENTAL

Financial Support

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Heba Iskandar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba Iskandar, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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The Emory Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00075262

Identifier Type: -

Identifier Source: org_study_id

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