GenomicsNCT00339794
Clinical Integration of Genetic Risk Assessment in Family Medicine
An observational study of Genomics, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study, conducted by the American Academy of Family Physicians (AAFP) and the National Human Genome Research Institute, will characterize family physicians' attitudes and practices related to the genetics of complex disorders. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Genomics
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2004to 16 Jul 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The sampling frame for this study is the American Academy of Family Physicians (AAFP) membership (estimated at 54,600 active members). The majority of the members of AAFP are physicians with a family physicians residency background (89%) who tend to practice in urban (71%), private office settings (89%) and provide direct patient care (82%).
Who cannot join
None listed.
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
This study, conducted by the American Academy of Family Physicians (AAFP) and the National Human Genome Research Institute, will characterize family physicians' attitudes and practices related to the genetics of complex disorders. As the front line of care for most Americans, family medicine will have a central role in seeing that new findings in genetics lead to disease prevention and health improvements. The information gained from this study could be useful in understanding and shaping the dissemination of genetic medicine in ways that improve the standard of primary care practice.
Members of the AAFP will be randomly selected from the organization's membership records to be invited to participate in this two-phase study. The first phase is a web-based survey of AAFP members. In the second phase, a sub-sample of those who complete the survey will be re-contacted; half will be members who have enrolled in a year-long web-based curriculum related to medical genetics, and the other half will be those who have chosen not to enroll in the curriculum.
Survey questions relate to the physicians' practices, knowledge, and opinions about implications of genomic medicine. Survey areas include family history taking; opinions about the future of genetics and family medicine; information about the physician and his or her practice; and physician's skills, attitudes and knowledge.
Read the detailed description
Although the evidence base for genetic susceptibility markers for complex disorders (e.g., diabetes, hypertension, and obesity) and the clinical utility of the related genetic tests has not been demonstrated, all signs suggest that genetics will become increasingly relevant to and integrated into family medicine. In recognition of these emerging genomic innovations and their potential for improving primary care practice, the American Academy of Family Physicians (AAFP), in collaboration with the National Human Genome Research Institute (NHGRI), has made genomic medicine the topic of their 2005 Annual Clinical Focus curriculum. The AAFP is one of the largest medical organizations with a membership that comprises a group of 56,400 active family physicians who deliver care in a broad array of practice settings in rural and urban communities around the United States, Puerto Rico, the Virgin Islands and Guam. This study seeks to take advantage of the plans for AAFP's clinical focus on genomics to characterize family physicians' attitudes and practices related to the genetics of complex disorders. This information could be useful in understanding and shaping the dissemination of genetic medicine in ways that improve the standard of primary care practice. To this end, we propose to conduct two phases of research activity. In the first phase, a web-based survey will be conducted of members of AAFP. In the second phase, a sub-sample of those who complete the survey will be re-contacted; half will be members who have enrolled in a year-long web-based curriculum related to medical genetics, and the other half will be those who have chosen not to enroll in the curriculum.
- Conditions
- Genomics
- Keywords
- Racial Profiling, Genomics, Genetic Testing, Family History, Family Physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 Dec 2004
- Study completion16 Jul 2010
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 GenomicsStudies 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
- Enrolment
- 1,500 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
- NCT00339794
- Sponsor's protocol ID
- 999905055
- Other IDs
- 05-HG-N055
- Status last verified
- 16 Jul 2010
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Sayers MD, Bellack AS, Wade JH, Bennett ME, Fong P. An empirical method for assessing social problem solving in schizophrenia. Behav Modif. 1995 Jul;19(3):267-89. doi: 10.1177/01454455950193001.
PubMed 7625993Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, Mountain JL, Perez-Stable EJ, Sheppard D, Risch N. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med. 2003 Mar 20;348(12):1170-5. doi: 10.1056/NEJMsb025007. No abstract available.
PubMed 12646676Burke W. Genetic testing. N Engl J Med. 2002 Dec 5;347(23):1867-75. doi: 10.1056/NEJMoa012113. No abstract available.
PubMed 12466512
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
- Clinical Integration of Genetic Risk Assessment in Family Medicine
- ClinicalTrials.gov ID
- NCT00339794
- Acronym / sponsor ID
- 999905055
- Conditions
- Genomics
- Keywords
- Racial Profiling, Genomics, Genetic Testing, Family History, Family Physician
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 7 Dec 2004
- Study completion
- 16 Jul 2010
- First posted
- 21 Jun 2006 (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.
This study, conducted by the American Academy of Family Physicians (AAFP) and the National Human Genome Research Institute, will characterize family physicians' attitudes and practices related to the genetics of complex disorders. As the front line of care for most Americans, family medicine will have a central role in seeing that new findings in genetics lead to disease prevention and health improvements. The information gained from this study could be useful in understanding and shaping the dissemination of genetic medicine in ways that improve the standard of primary care practice.
Members of the AAFP will be randomly selected from the organization's membership records to be invited to participate in this two-phase study. The first phase is a web-based survey of AAFP members. In the second phase, a sub-sample of those who complete the survey will be re-contacted; half will be members who have enrolled in a year-long web-based curriculum related to medical genetics, and the other half will be those who have chosen not to enroll in the curriculum.
Survey questions relate to the physicians' practices, knowledge, and opinions about implications of genomic medicine. Survey areas include family history taking; opinions about the future of genetics and family medicine; information about the physician and his or her practice; and physician's skills, attitudes and knowledge.
Detailed description
Although the evidence base for genetic susceptibility markers for complex disorders (e.g., diabetes, hypertension, and obesity) and the clinical utility of the related genetic tests has not been demonstrated, all signs suggest that genetics will become increasingly relevant to and integrated into family medicine. In recognition of these emerging genomic innovations and their potential for improving primary care practice, the American Academy of Family Physicians (AAFP), in collaboration with the National Human Genome Research Institute (NHGRI), has made genomic medicine the topic of their 2005 Annual Clinical Focus curriculum. The AAFP is one of the largest medical organizations with a membership that comprises a group of 56,400 active family physicians who deliver care in a broad array of practice settings in rural and urban communities around the United States, Puerto Rico, the Virgin Islands and Guam. This study seeks to take advantage of the plans for AAFP's clinical focus on genomics to characterize family physicians' attitudes and practices related to the genetics of complex disorders. This information could be useful in understanding and shaping the dissemination of genetic medicine in ways that improve the standard of primary care practice. To this end, we propose to conduct two phases of research activity. In the first phase, a web-based survey will be conducted of members of AAFP. In the second phase, a sub-sample of those who complete the survey will be re-contacted; half will be members who have enrolled in a year-long web-based curriculum related to medical genetics, and the other half will be those who have chosen not to enroll in the curriculum.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The sampling frame for this study is the American Academy of Family Physicians (AAFP) membership (estimated at 54,600 active members). The majority of the members of AAFP are physicians with a family physicians residency background (89%) who tend to practice in urban (71%), private office settings (89%) and provide direct patient care (82%).
Key exclusion criteria (0 listed)
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 7625993Sayers MD, Bellack AS, Wade JH, Bennett ME, Fong P. An empirical method for assessing social problem solving in schizophrenia. Behav Modif. 1995 Jul;19(3):267-89. doi: 10.1177/01454455950193001.
- Background: PubMed 12646676Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, Mountain JL, Perez-Stable EJ, Sheppard D, Risch N. The importance of race and ethnic background in biomedical research and clinical practice. N Engl J Med. 2003 Mar 20;348(12):1170-5. doi: 10.1056/NEJMsb025007. No abstract available.
- Background: PubMed 12466512Burke W. Genetic testing. N Engl J Med. 2002 Dec 5;347(23):1867-75. doi: 10.1056/NEJMoa012113. No abstract available.
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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 Genomics, 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 1 inclusion and 0 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 NCT00339794, 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.