- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911833
The Roles of Trust and Respect in Patient Reactions to Race-based and Personalized Medicine Vignettes: An Experimental Study
The Roles of Trust and Respect in Patient Reactions to Race-Based and Personalized Medicine Vignettes: An Experimental Study
Background:
- Genetic research has implications for drug development and marketing. Race-based medicine may be able to provide specific treatment for populations with increased disease-specific morbidity and mortality. However, contemporary genetic research refutes the idea that races are genetically distinct populations, even as drugs designed for use in specific races are being promoted.
- Studies have shown high levels of public suspicion for race-based and personalized genetic medicine. Concerns related to not only the potential performance of race-based drugs, but also the motives of those offering these drugs. Many participants have suggested conspiracy theories in which race-based medicine was disguising an attempt to provide inferior medications or deliberately harm certain populations. Concerns about personalized medicine often have to do with privacy and other personal concerns.
- Public suspicions of race-based medicine, and to a lesser extent, personalized genetic medicine, make it important to examine and understand the theoretical and empirical literature on trust and health care.
Objective:
- To describe the perspective of participants evaluating the medicine offer.
Eligibility:
- Males and females ages 18 and older who are visiting the John Hopkins clinics (primarily the adult care clinics).
- Participants must be able to take a literacy screen and respond to a short survey.
Design:
- Participants will be asked to take a researcher-administrated literacy screen, read one of three randomly assigned vignettes, and fill out a survey. The first page of the survey will provide information about the study.
- Participants will respond to initial questions about demographics, experiences with discrimination, and trust in the medical profession and institutions.
- Each participant will receive a random vignette in which he/she will imagine him/herself being diagnosed with a common, chronic condition and offered a conventional drug, a race-based drug, or a genetically personalized drug.
- After being presented with the vignette, participants will be asked to respond to a survey that asks about their levels of trust in the vignette doctor, perceived respect given to the patient by the vignette physician, emotional response to the vignette, their belief in the effectiveness and safety of the drug prescribed in the vignette, information sufficiency, and their hypothetical behavioral intention to take the drug.
- Participants will be debriefed after completing the survey, and will be offered a small amount of compensation for participating.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Participants are primarily African American or white, have a high prevalence of chronic disease, and a moderate prevalence of limited literacy.
Participants must be 18 or older.
EXCLUSION CRITERIA:
Participants who do not speak English and cannot read the survey (due to linguistic barriers) will be excluded.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- Beach MC, Roter DL, Wang NY, Duggan PS, Cooper LA. Are physicians' attitudes of respect accurately perceived by patients and associated with more positive communication behaviors? Patient Educ Couns. 2006 Sep;62(3):347-54. doi: 10.1016/j.pec.2006.06.004. Epub 2006 Jul 21.
- Beach MC, Sugarman J, Johnson RL, Arbelaez JJ, Duggan PS, Cooper LA. Do patients treated with dignity report higher satisfaction, adherence, and receipt of preventive care? Ann Fam Med. 2005 Jul-Aug;3(4):331-8. doi: 10.1370/afm.328.
- Bevan JL, Lynch JA, Dubriwny TN, Harris TM, Achter PJ, Reeder AL, Condit CM. Informed lay preferences for delivery of racially varied pharmacogenomics. Genet Med. 2003 Sep-Oct;5(5):393-9. doi: 10.1097/01.gim.0000087989.12317.3f.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999909153
- 09-HG-N153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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