HealthyNCT00316056
Use of Virtual Reality to Communicate Concepts of Genomics to the General Public
An observational study of Healthy and Learning, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will investigate how people learn best about genetics. It involves participating in activities in NHGRI's Immersive Virtual Environment Laboratory (IVE lab), where digital "virtual worlds" are created that appear to surround the subject when he or she wears a head-mounted display. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy, Learning, Communication
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2006to 17 Oct 2007
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants in this study will be healthy adult volunteers. Eligibility criteria for the study are: (1) being 18-40 years of age; (2) being able to speak English and having basic English reading and writing skills; and (3) not having taken a genetics course in the past five years. Both men and women will be included in the study. We will exclude women in their last trimester of pregnancy from the study, due to the small chance of study participants tripping or bumping into walls.
- Because we are interested in how members of the general public learn best about genomic topics, participants in this study will be healthy adults. Individuals who are particularly susceptible to motion sickness will be excluded. Therefore, all participants will be screened for the following conditions prior to enrollment in the study: self-reported diagnosis with epilepsy, low vision, hearing problems, or vestibular disorders (e.g., dizziness, vertigo, motion sickness).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Using Virtual Reality to Test Communication Strategies for Genomic Concepts
This study will investigate how people learn best about genetics. It involves participating in activities in NHGRI's Immersive Virtual Environment Laboratory (IVE lab), where digital "virtual worlds" are created that appear to surround the subject when he or she wears a head-mounted display.
English-speaking men and women between 18 and 40 years of age may be eligible for this study. Participants are randomly assigned to one of two groups, each of which receives a different type of information, once in the IVE lab. Subjects complete a questionnaire before and after performing the activities in the lab. The questionnaire evaluates the subject's knowledge of genetics and tests some reading and number skills.
...
Read the detailed description
This study will be the foundation of an innovative program of research designed to investigate how to communicate the complex concepts of genomics to the general public. The focus of the study will be one particular concept, the idea that genetic and environmental factors interact to affect risk of common diseases. One objective of this study will be to examine the effects of pedagogical modality (i.e., learning mode) on conceptual understanding (i.e., comprehension). A learning-by-doing (i.e., self-driven, interactive activities) condition will be compared to a learning-by-assimilation (i.e., lecture) condition to assess the effects on comprehension. The second objective of the study is to examine possible moderation of the hypothesized relationship between learning mode and comprehension by health literacy or genetic literacy (i.e., literacy skills related to these specific content areas). The third study objective is to explore possible mediators of the relationship between learning mode and comprehension. These experiments will be conducted in the NIH Immersive Virtual Environment Testing area in order to hold presentation medium constant while comparing the two learning modes. 150 participants will be for the experimental comparison phase. Because in the primary focus of the study is how the general public learns best, study participants will be healthy adult volunteers without specialized genetics knowledge. Exclusion criteria include self-reported diagnosis with epilepsy, vision or hearing problems, and vestibular disorders (e.g., dizziness, vertigo, motion sickness). Two learning-by-doing virtual environments (IVEs) and two learning-by-assimilation IVEs have been developed and pilot tested, and the IVEs that best convey the idea of gene-environment interactions have been selected for the experimental comparison. Participants will be randomized to one of two conditions: Learning-by-doing or Learning-by-assimilation; each participant will complete one IVE. The study will have two primary outcomes, both measures of comprehension: a fourteen-item measure of recall (i.e., remembering content as presented) and a six-item measure of transfer (i.e., applying content to new situations). These data will provide a foundation for a program of research investigating how best to communicate genomic concepts to the general public and, eventually, the development of effective genomic communication strategies for disease prevention interventions.
- Conditions
- Healthy, Learning, Communication
- Keywords
- Genetic Literacy, Learning, Genetic Knowledge, Public Understanding of Science, Science Education, Healthy Volunteer, HV
- Medical subject headings
- Communication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study start14 Apr 2006
- Primary completion17 Oct 2007
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 HealthyStudies 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
- 346 participants
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
- NCT00316056
- Sponsor's protocol ID
- 060143
- Other IDs
- 06-HG-0143
- Status last verified
- 25 Aug 2009
- First submitted
- 18 Apr 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bailenson JN, Blascovich J, Beall AC, Loomis JM. Interpersonal distance in immersive virtual environments. Pers Soc Psychol Bull. 2003 Jul;29(7):819-33. doi: 10.1177/0146167203029007002.
PubMed 15018671Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.
PubMed 14528569Collins FS, McKusick VA. Implications of the Human Genome Project for medical science. JAMA. 2001 Feb 7;285(5):540-4. doi: 10.1001/jama.285.5.540.
PubMed 11176855
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
- Using Virtual Reality to Test Communication Strategies for Genomic Concepts
- ClinicalTrials.gov ID
- NCT00316056
- Acronym / sponsor ID
- 060143
- Conditions
- Healthy, Learning, Communication
- Keywords
- Genetic Literacy, Learning, Genetic Knowledge, Public Understanding of Science, Science Education, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 14 Apr 2006
- Primary completion
- 17 Oct 2007 (actual)
- First posted
- 19 Apr 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 will investigate how people learn best about genetics. It involves participating in activities in NHGRI's Immersive Virtual Environment Laboratory (IVE lab), where digital "virtual worlds" are created that appear to surround the subject when he or she wears a head-mounted display.
English-speaking men and women between 18 and 40 years of age may be eligible for this study. Participants are randomly assigned to one of two groups, each of which receives a different type of information, once in the IVE lab. Subjects complete a questionnaire before and after performing the activities in the lab. The questionnaire evaluates the subject's knowledge of genetics and tests some reading and number skills.
...
Detailed description
This study will be the foundation of an innovative program of research designed to investigate how to communicate the complex concepts of genomics to the general public. The focus of the study will be one particular concept, the idea that genetic and environmental factors interact to affect risk of common diseases. One objective of this study will be to examine the effects of pedagogical modality (i.e., learning mode) on conceptual understanding (i.e., comprehension). A learning-by-doing (i.e., self-driven, interactive activities) condition will be compared to a learning-by-assimilation (i.e., lecture) condition to assess the effects on comprehension. The second objective of the study is to examine possible moderation of the hypothesized relationship between learning mode and comprehension by health literacy or genetic literacy (i.e., literacy skills related to these specific content areas). The third study objective is to explore possible mediators of the relationship between learning mode and comprehension. These experiments will be conducted in the NIH Immersive Virtual Environment Testing area in order to hold presentation medium constant while comparing the two learning modes. 150 participants will be for the experimental comparison phase. Because in the primary focus of the study is how the general public learns best, study participants will be healthy adult volunteers without specialized genetics knowledge. Exclusion criteria include self-reported diagnosis with epilepsy, vision or hearing problems, and vestibular disorders (e.g., dizziness, vertigo, motion sickness). Two learning-by-doing virtual environments (IVEs) and two learning-by-assimilation IVEs have been developed and pilot tested, and the IVEs that best convey the idea of gene-environment interactions have been selected for the experimental comparison. Participants will be randomized to one of two conditions: Learning-by-doing or Learning-by-assimilation; each participant will complete one IVE. The study will have two primary outcomes, both measures of comprehension: a fourteen-item measure of recall (i.e., remembering content as presented) and a six-item measure of transfer (i.e., applying content to new situations). These data will provide a foundation for a program of research investigating how best to communicate genomic concepts to the general public and, eventually, the development of effective genomic communication strategies for disease prevention interventions.
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants in this study will be healthy adult volunteers. Eligibility criteria for the study are: (1) being 18-40 years of age; (2) being able to speak English and having basic English reading and writing skills; and (3) not having taken a genetics course in the past five years. Both men and women will be included in the study. We will exclude women in their last trimester of pregnancy from the study, due to the small chance of study participants tripping or bumping into walls.
- Because we are interested in how members of the general public learn best about genomic topics, participants in this study will be healthy adults. Individuals who are particularly susceptible to motion sickness will be excluded. Therefore, all participants will be screened for the following conditions prior to enrollment in the study: self-reported diagnosis with epilepsy, low vision, hearing problems, or vestibular disorders (e.g., dizziness, vertigo, motion sickness).
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 15018671Bailenson JN, Blascovich J, Beall AC, Loomis JM. Interpersonal distance in immersive virtual environments. Pers Soc Psychol Bull. 2003 Jul;29(7):819-33. doi: 10.1177/0146167203029007002.
- Background: PubMed 14528569Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.
- Background: PubMed 11176855Collins FS, McKusick VA. Implications of the Human Genome Project for medical science. JAMA. 2001 Feb 7;285(5):540-4. doi: 10.1001/jama.285.5.540.
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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 Healthy and Learning, 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 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 NCT00316056, 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.