Crohn's DiseaseNCT00968721
Decisional Influences and Inflammatory Bowel Disease (IBD) Patients' Medication Use
An observational study of Crohn's Disease and Ulcerative Colitis, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Vanderbilt University Medical Center patients unable to take the survey because they do not have an e-mail address or access to one.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inflammatory Bowel Disease Clinic c/o Divison of Gastroenterology, Hepatology and Nutrition, Department of Medicine, School of Medicine, Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: Decisional Influences and IBD Patients' Medication Use
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.
Read the 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?
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Inflammatory bowel disease, Crohn's disease, Ulcerative colitis, medication adherence, Decisional influences
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
What influences do therapeutic values, task difficulty, physician-patient relationship, information sources, personal beliefs and values have on patients' IBd medication adherence?
Measured: 1 year
Secondary outcomes (2)
What are the relationships between decision influences and illness activity?
Measured: 1 year
What associations exist among decision influences, illness activity, medication adherence and utilization of IBD Clinic services?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: lack of support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Lawrence S Gaines, Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968721
- Sponsor's protocol ID
- 090527
- Status last verified
- Apr 2016
- First submitted
- 28 Aug 2009
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cerveny P, Bortlik M, Kubena A, Vlcek J, Lakatos PL, Lukas M. Nonadherence in inflammatory bowel disease: results of factor analysis. Inflamm Bowel Dis. 2007 Oct;13(10):1244-9. doi: 10.1002/ibd.20189.
PubMed 17538983Ediger JP, Walker JR, Graff L, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, McPhail C, Deering K, Bernstein CN. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007 Jul;102(7):1417-26. doi: 10.1111/j.1572-0241.2007.01212.x. Epub 2007 Apr 16.
PubMed 17437505Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.
PubMed 6102236Hicks FD, Holm K. Self-management decision influences in heart failure: a preliminary investigation. Clin Nurs Res. 2003 Feb;12(1):69-84. doi: 10.1177/1054773803238741.
PubMed 12583500Horne, R. The medication adherence report scale. University of Brighton, Brighton, UK, 2004.
Johnson MJ. The Medication Adherence Model: a guide for assessing medication taking. Res Theory Nurs Pract. 2002 Fall;16(3):179-92. doi: 10.1891/rtnp.16.3.179.53008.
PubMed 12472293Kane SV, Brixner D, Rubin DT, Sewitch MJ. The challenge of compliance and persistence: focus on ulcerative colitis. J Manag Care Pharm. 2008 Jan;14(1 Suppl A):s2-12; quiz s13-5. doi: 10.18553/jmcp.2008.14.s1-a.1a.
PubMed 18240888Kane SV, Loftus EV Jr, Dubinsky MC, Sederman R. Disease perceptions among people with Crohn's disease. Inflamm Bowel Dis. 2008 Aug;14(8):1097-101. doi: 10.1002/ibd.20418.
PubMed 18338774Riegel B, Carlson B, Moser DK, Sebern M, Hicks FD, Roland V. Psychometric testing of the self-care of heart failure index. J Card Fail. 2004 Aug;10(4):350-60. doi: 10.1016/j.cardfail.2003.12.001.
PubMed 15309704Sewitch MJ, Abrahamowicz M, Dobkin PL, Tamblyn R. Measuring differences between patients' and physicians' health perceptions: the patient-physician discordance scale. J Behav Med. 2003 Jun;26(3):245-64. doi: 10.1023/a:1023412604715.
PubMed 12845937Sewitch MJ, Abrahamowicz M, Barkun A, Bitton A, Wild GE, Cohen A, Dobkin PL. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol. 2003 Jul;98(7):1535-44. doi: 10.1111/j.1572-0241.2003.07522.x.
PubMed 12873575Powell-Tuck J, Bown RL, Lennard-Jones JE. A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis. Scand J Gastroenterol. 1978;13(7):833-7. doi: 10.3109/00365527809182199.
PubMed 364626Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.
PubMed 12136497
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Influences and IBD Patients' Medication Use
- ClinicalTrials.gov ID
- NCT00968721
- Acronym / sponsor ID
- 090527
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Inflammatory bowel disease, Crohn's disease, Ulcerative colitis, medication adherence, Decisional influences
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of support
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Vanderbilt University Medical Center patients unable to take the survey because they do not have an e-mail address or access to one.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: lack of support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Background: PubMed 17538983Cerveny P, Bortlik M, Kubena A, Vlcek J, Lakatos PL, Lukas M. Nonadherence in inflammatory bowel disease: results of factor analysis. Inflamm Bowel Dis. 2007 Oct;13(10):1244-9. doi: 10.1002/ibd.20189.
- Background: PubMed 17437505Ediger JP, Walker JR, Graff L, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, McPhail C, Deering K, Bernstein CN. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007 Jul;102(7):1417-26. doi: 10.1111/j.1572-0241.2007.01212.x. Epub 2007 Apr 16.
- Background: PubMed 6102236Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.
- Background: PubMed 12583500Hicks FD, Holm K. Self-management decision influences in heart failure: a preliminary investigation. Clin Nurs Res. 2003 Feb;12(1):69-84. doi: 10.1177/1054773803238741.
- BackgroundHorne, R. The medication adherence report scale. University of Brighton, Brighton, UK, 2004.
- Background: PubMed 12472293Johnson MJ. The Medication Adherence Model: a guide for assessing medication taking. Res Theory Nurs Pract. 2002 Fall;16(3):179-92. doi: 10.1891/rtnp.16.3.179.53008.
- Background: PubMed 18240888Kane SV, Brixner D, Rubin DT, Sewitch MJ. The challenge of compliance and persistence: focus on ulcerative colitis. J Manag Care Pharm. 2008 Jan;14(1 Suppl A):s2-12; quiz s13-5. doi: 10.18553/jmcp.2008.14.s1-a.1a.
- Background: PubMed 18338774Kane SV, Loftus EV Jr, Dubinsky MC, Sederman R. Disease perceptions among people with Crohn's disease. Inflamm Bowel Dis. 2008 Aug;14(8):1097-101. doi: 10.1002/ibd.20418.
- Background: PubMed 15309704Riegel B, Carlson B, Moser DK, Sebern M, Hicks FD, Roland V. Psychometric testing of the self-care of heart failure index. J Card Fail. 2004 Aug;10(4):350-60. doi: 10.1016/j.cardfail.2003.12.001.
- Background: PubMed 12845937Sewitch MJ, Abrahamowicz M, Dobkin PL, Tamblyn R. Measuring differences between patients' and physicians' health perceptions: the patient-physician discordance scale. J Behav Med. 2003 Jun;26(3):245-64. doi: 10.1023/a:1023412604715.
- Background: PubMed 12873575Sewitch MJ, Abrahamowicz M, Barkun A, Bitton A, Wild GE, Cohen A, Dobkin PL. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol. 2003 Jul;98(7):1535-44. doi: 10.1111/j.1572-0241.2003.07522.x.
- Background: PubMed 364626Powell-Tuck J, Bown RL, Lennard-Jones JE. A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis. Scand J Gastroenterol. 1978;13(7):833-7. doi: 10.3109/00365527809182199.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence S Gaines, Ph.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968721, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.