DiabetesNCT00911833
The Roles of Trust and Respect in Patient Reactions to Race-based and Personalized Medicine Vignettes: An Experimental Study
An observational study of Diabetes and Congenital Heart Disease, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Congenital Heart Disease, Hypertension
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2009to 30 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who do not speak English and cannot read the survey (due to linguistic barriers) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
This study proposes to describe participants' attitudinal, emotional, cognitive, and hypothetical behavioral responses to randomized hypothetical vignettes illustrating the prescription of conventional, race-based, and genetically personalized medicine for a common chronic condition. This study is theoretically guided by conceptualizations of relationship-centered care and the risk information seeking and processing model. These theories recognize the importance of interpersonal influence within health care interactions, underscore the moral dimensions of patient-physician relationships, and describe the predictors of how information is attended to and processed. An experimental, mixed methods design will be used to randomly assign 357 patients at the Johns Hopkins clinics to one of three vignettes illustrating conventional, race-based, and genetically personalized medication offers. This study aims to examine the effects of the type of medication offer (conventional, race-based, and genetically personalized) and certain participant characteristics (race, literacy, background healthcare trust/experience with discrimination) on attitudinal, emotional, cognitive, and hypothetical behavioral responses; to determine if the relationships among the type of medication offer and the four categories of outcomes are moderated by race and mediated by trust; and to describe the participants' perspective on the vignette, through targeted open-ended questions.
- Conditions
- Diabetes, Congenital Heart Disease, Hypertension
- Keywords
- Trust
- Medical subject headings
- Diabetes Mellitus, Heart Defects, Congenital, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study start19 May 2009
- Study completion30 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911833
- Sponsor's protocol ID
- 999909153
- Other IDs
- 09-HG-N153
- Status last verified
- 30 Mar 2011
- First submitted
- 29 May 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
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.
PubMed 16859867Beach 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.
PubMed 16046566Bevan 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.
PubMed 14501835
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of Trust and Respect in Patient Reactions to Race-Based and Personalized Medicine Vignettes: An Experimental Study
- ClinicalTrials.gov ID
- NCT00911833
- Acronym / sponsor ID
- 999909153
- Conditions
- Diabetes, Congenital Heart Disease, Hypertension
- Keywords
- Trust
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 19 May 2009
- Study completion
- 30 Mar 2011
- First posted
- 2 Jun 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.
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.
Detailed description
This study proposes to describe participants' attitudinal, emotional, cognitive, and hypothetical behavioral responses to randomized hypothetical vignettes illustrating the prescription of conventional, race-based, and genetically personalized medicine for a common chronic condition. This study is theoretically guided by conceptualizations of relationship-centered care and the risk information seeking and processing model. These theories recognize the importance of interpersonal influence within health care interactions, underscore the moral dimensions of patient-physician relationships, and describe the predictors of how information is attended to and processed. An experimental, mixed methods design will be used to randomly assign 357 patients at the Johns Hopkins clinics to one of three vignettes illustrating conventional, race-based, and genetically personalized medication offers. This study aims to examine the effects of the type of medication offer (conventional, race-based, and genetically personalized) and certain participant characteristics (race, literacy, background healthcare trust/experience with discrimination) on attitudinal, emotional, cognitive, and hypothetical behavioral responses; to determine if the relationships among the type of medication offer and the four categories of outcomes are moderated by race and mediated by trust; and to describe the participants' perspective on the vignette, through targeted open-ended questions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who do not speak English and cannot read the survey (due to linguistic barriers) will be excluded.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16859867Beach 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.
- Background: PubMed 16046566Beach 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.
- Background: PubMed 14501835Bevan 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes and Congenital Heart Disease, run by National Human Genome Research Institute (NHGRI) 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: finished, as of the sponsor's last update on 2 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911833, which also lists 3 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 Jul 2017.