Decisional Influences and Inflammatory Bowel Disease (IBD) Patients' Medication Use

Terminated

• Conditions: Ulcerative Colitis; Crohn's Disease

• Registration Number: NCT00968721
• Lead Sponsor: Vanderbilt University

Brief Summary

The primary purpose of this study is to pilot test an instrument that the investigators will develop to assess decision influences on inflammatory bowel disease patients' medication adherence decision-making.

This pilot study will use an exploratory, descriptive cross-sectional survey approach to pilot test the instrument and answer the research questions.

The main hypothesis is that patients at risk for intentionally modifying their prescribed medication regimen will differ on influences on decision-making, health status, and utilization of the IBD clinic services compared to those who are intentionally adherent and who continue adherence over time.

Detailed Description

Clinical research has produced significant advances in the pharmacologic management of inflammatory bowel disease (IBD). Preliminary research, however, suggest that patient non-adherence may be blunting medication effectiveness. The etiology of medication non-adherence likely depends on several coexisting factors. We believe that naturalistic decision making links patient level/ "micro" variables to services-level/ "macro" variables and behavioral outcomes. Every day, natural decisions about medication use are likely made in the context of patients' experience of their illness, knowledge about the illness and treatments, the physician-patient relationship, personal priorities and values, and other influences related to deciding to use medicine. By their very nature, illness related decisions are uncertain and risky because outcomes are unknown and patients often have limited knowledge and experience of the progression of their chronic illness. During the progression of an illness, patients may experiment with and analyze risks and benefits of therapies and relying on interpersonal interaction with health-care professionals to determine the self-management strategies best suited to patients and their life goals. Patient decision-making is thus and iterative process that evolves over time. An understanding of medication use decisions requires the description and understanding of those decision influences that may affect medication use decision-making over the course of the illness. Therefore, the primary purpose of this study is to develop and test a psychometric instrument that assesses influences on patients' decisions to use/not use their IBD medication.

The main hypothesis underlying the instrument development project is that patients at risk for intentionally modifying their prescribed medication regimen will differ on influences on decision-making, health status, and utilization of the IBD clinic services compared to those who are intentionally adherent and who continue adherence over time.

The following questions will be studied:

* What influences do therapeutic values, task difficulty, physician-patient relationship, information sources, personal beliefs and values have on patients' IBd medication adherence?

* What are the relationships between decision influences and illness activity?

* What associations exist among decision influences, illness activity, medication adherence and utilization of IBD Clinic services?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2010-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• All Vanderbilt University Medical Center IBD patients that are 18 years or older
• Those who volunteered to participate in this online web-based survey study.

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Exclusion Criteria

• Vanderbilt University Medical Center patients unable to take the survey because they do not have an e-mail address or access to one.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What influences do therapeutic values, task difficulty, physician-patient relationship, information sources, personal beliefs and values have on patients' IBd medication adherence?	1 year

Secondary Outcome Measures

Name	Time	Method
What are the relationships between decision influences and illness activity?	1 year
What associations exist among decision influences, illness activity, medication adherence and utilization of IBD Clinic services?	1 year

Trial Locations

Locations (1)

Inflammatory Bowel Disease Clinic c/o Divison of Gastroenterology, Hepatology and Nutrition, Department of Medicine, School of Medicine, Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States