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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00968721
First received: August 28, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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
Crohn's Disease
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Decisional Influences and IBD Patients' Medication Use

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • What are the relationships between decision influences and illness activity? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • What associations exist among decision influences, illness activity, medication adherence and utilization of IBD Clinic services? [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBD patients

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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The Vanderbilt University Medical Center Research Recruitment Registry will be used to identify the medical record and phone numbers of all VUMC patients recieving treatment for IBD.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968721

Contacts
Contact: Lawrence S Gaines, Ph.D. 615-322-0128 lawrence.gaines@vanderbilt.edu
Contact: David A Schwartz, M.D. 615-343-8174 david.a.schwartz@vanderbilt.edu

Locations
United States, Tennessee
Inflammatory Bowel Disease Clinic c/o Divison of Gastroenterology, Hepatology and Nutrition, Department of Medicine, School of Medicine, Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Lawrence S Gaines, Ph.D.         
Sub-Investigator: David A Schwartz, M.D.         
Sub-Investigator: Gloria Hamilton, Ph.D.         
Sponsors and Collaborators
Vanderbilt University
Procter and Gamble
Investigators
Principal Investigator: Lawrence S Gaines, Ph.D. Vanderbilt University
  More Information

Publications:

Responsible Party: Lawrence S. Gaines, Ph.D, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00968721     History of Changes
Other Study ID Numbers: 090527
Study First Received: August 28, 2009
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
medication adherence
Decisional influences

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014