Decisional Influences and Inflammatory Bowel Disease (IBD) Patients' Medication Use
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|ClinicalTrials.gov Identifier: NCT00968721|
Recruitment Status : Terminated (lack of support)
First Posted : August 31, 2009
Last Update Posted : May 2, 2016
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.
|Condition or disease|
|Crohn's Disease Ulcerative Colitis|
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?
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Decisional Influences and IBD Patients' Medication Use|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
- What influences do therapeutic values, task difficulty, physician-patient relationship, information sources, personal beliefs and values have on patients' IBd medication adherence? [ Time Frame: 1 year ]
- What are the relationships between decision influences and illness activity? [ Time Frame: 1 year ]
- What associations exist among decision influences, illness activity, medication adherence and utilization of IBD Clinic services? [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968721
|United States, Tennessee|
|Inflammatory Bowel Disease Clinic c/o Divison of Gastroenterology, Hepatology and Nutrition, Department of Medicine, School of Medicine, Vanderbilt University|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Lawrence S Gaines, Ph.D.||Vanderbilt University Medical Center|