Healthy VolunteerNCT00669188
Patient Provider Communication and Interaction in a Virtual Clinical Setting
A study testing Information absent and Information in people with Healthy Volunteer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Summary: A few studies have explored factors which influence patient-provider communication in a controlled setting. However, more information is needed about how different factors affect communication so that it can be improved. Third- and fourth-year medical students may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Information absent and Information
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2008to 8 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- Healthy adult volunteers who are third or fourth-year medical students. Both men and women over age 18 will be eligible for this study (though in practice the age range is likely to naturally be constrained by the typical age of medical students).
- EXCLUSION CRITERIA: 1) persons with seizure or vestibular disorders; 2) women with known pregnancy; 3) persons who are highly prone to motion sickness; 4) those with low, uncorrected vision or hearing; 5) all current and past employees and contractors of
- NHGRI; and 6) persons who have received information about the study purpose or procedure from a past participant.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Patient-Provider Communication and Interaction in a Virtual Clinical Setting
Summary:
A few studies have explored factors which influence patient-provider communication in a controlled setting. However, more information is needed about how different factors affect communication so that it can be improved.
Read more
Third- and fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.
At the research center, participants will use a virtual reality headset to view a virtual clinic environment and interact with a virtual patient.
After interacting with the virtual patient, participants will complete a questionnaire about their experience within the virtual clinic and other research-related information.
The total time for the study visit is 60 minutes.
Eligibility:
Third- and fourth-year medical students at least 18 years of age. You may not take part in the study if you have a history of seizures and/or are pregnant.
Read the detailed description
This study will investigate research questions regarding factors influencing patient-provider communication. Participants will interact with a virtual patient in a virtual clinical setting.
Third- or fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.
Study participants will perform one task and complete one set of questions at the study appointment. The task involves viewing a virtual patient s health information and interacting with the virtual patient in a virtual environment clinical scenario. While in the virtual environment, the subject wears a head-mounted video unit that allows him or her to see elements of the environment. The activities in the virtual environment take about 15 minutes. The total time for the study is about 60 minutes.
- Conditions
- Healthy Volunteer
- Being tested
- Information absent, Information
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information absentOther
Information
InformationOther
Information
| Study group | Role | What they receive |
|---|---|---|
| Information Type 1 | Experimental | genetic risk information Receives: Other: Information |
| Information Type 2 | Sham comparator | information absent Receives: Other: Information absent |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment recommendations
recommendations made for the virtual patient's treatment
Measured: at time of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study start24 Apr 2008
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan Persky, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669188
- Sponsor's protocol ID
- 080122
- Other IDs
- 08-HG-0122
- Status last verified
- 9 Jan 2024
- First submitted
- 29 Apr 2008
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Provider Communication and Interaction in a Virtual Clinical Setting
- ClinicalTrials.gov ID
- NCT00669188
- Acronym / sponsor ID
- 080122
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 24 Apr 2008 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 30 Apr 2008 (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.
Summary:
A few studies have explored factors which influence patient-provider communication in a controlled setting. However, more information is needed about how different factors affect communication so that it can be improved.
Third- and fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.
At the research center, participants will use a virtual reality headset to view a virtual clinic environment and interact with a virtual patient.
After interacting with the virtual patient, participants will complete a questionnaire about their experience within the virtual clinic and other research-related information.
The total time for the study visit is 60 minutes.
Eligibility:
Third- and fourth-year medical students at least 18 years of age. You may not take part in the study if you have a history of seizures and/or are pregnant.
Detailed description
This study will investigate research questions regarding factors influencing patient-provider communication. Participants will interact with a virtual patient in a virtual clinical setting.
Third- or fourth-year medical students may be eligible for this study. Participants are recruited from the Washington, D.C. area.
Study participants will perform one task and complete one set of questions at the study appointment. The task involves viewing a virtual patient s health information and interacting with the virtual patient in a virtual environment clinical scenario. While in the virtual environment, the subject wears a head-mounted video unit that allows him or her to see elements of the environment. The activities in the virtual environment take about 15 minutes. The total time for the study is about 60 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Type 1 | Experimental | Other: Informationgenetic risk information |
| Information Type 2 | Sham comparator | Other: Information absentinformation absent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers who are third or fourth-year medical students. Both men and women over age 18 will be eligible for this study (though in practice the age range is likely to naturally be constrained by the typical age of medical students).
- EXCLUSION CRITERIA: 1) persons with seizure or vestibular disorders; 2) women with known pregnancy; 3) persons who are highly prone to motion sickness; 4) those with low, uncorrected vision or hearing; 5) all current and past employees and contractors of
- NHGRI; and 6) persons who have received information about the study purpose or procedure from a past participant.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information absentInformation | Other | Information Type 2 |
| InformationInformation | Other | Information Type 1 |
Primary outcome
treatment recommendations
Time frame: at time of study
recommendations made for the virtual patient's treatment
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 12 Aug 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Screening Protocol
Pain
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.
Susan Persky, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information absent and Information in people with Healthy Volunteer, 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 3 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 12 Aug 2024. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
treatment recommendations (time frame: at time of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2024.