View Clinical Trial (Medical Research Study)
Decisional Influences and IBD Patients' Medication Use
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Crohn's Disease - Ulcerative Colitis |
| Purpose: |
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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.
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| Study Summary: |
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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?
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| Criteria: |
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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.
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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| NCT ID: |
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NCT00968721 |
| Primary Contact: |
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Principal Investigator
Lawrence S Gaines, Ph.D.
Vanderbilt University
Lawrence S Gaines, Ph.D.
Phone: 615-322-0128
Email: lawrence.gaines@vanderbilt.edu
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| Backup Contact: |
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Email: david.a.schwartz@vanderbilt.edu
David A Schwartz, M.D.
Phone: 615-343-8174
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| Location Contact: |
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Nashville, Tennessee 37232
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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