Heart DiseaseVICKYNCT02344433
Using Virtual Counselors to Overcome Genetic Literacy Barriers
A study testing VICKY and MFHP in people with Heart Disease and Stroke, run by Boston University.
Trial summary
A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Stroke, Diabetes
- What is being tested?
- VICKY and MFHP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Oct 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older;
- current Boston Medical Center patient - must have an upcoming returning patient appointment at Boston Medical Center or affiliated clinic within 3 months of recruitment;
- speaks English and/or Spanish.
Who cannot join
- Under 21 years of age;
- not a current patient of Boston Medical Center or affiliated clinic;
- unable to speak English and/or Spanish.
About this study
Official title: Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY
A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.
- Conditions
- Heart Disease, Stroke, Diabetes, Cancer
- Being tested
- VICKY, MFHP
- Keywords
- Family health history, Genetic literacy, Health literacy, Relational agent, Common chronic conditions
- Medical subject headings
- Heart Diseases, Stroke, Diabetes Mellitus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VICKYBehavioural
Relational agent/virtual counselor
MFHPBehavioural
US Surgeon General's family history tool
| Study group | Role | What they receive |
|---|---|---|
| VICKY | Experimental | Relational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History). Receives: Behavioral: VICKY |
| MFHP | Active comparator | Online family health history collection tool (MFHP: My Family Health Portrait). Receives: Behavioral: MFHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of health conditions id'd (interview w/ genetic counselor gold standard. health conditions id'd by VICKY or MFHP id'd by genetic counselor (true +) divided by health conditions captured by genetic counselor (false - plus true +)
Sensitivity will be calculated using an interview with a genetic counselor as the gold standard. Sensitivity will be defined as the health conditions identified by the family health history tool (VICKY or MFHP) that were also identified by the genetic counselor (true positive) divided by the health conditions not captured by the tool but captured by the genetic counselor (false negatives) plus the true positives.
Measured: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Accuracy of family members identified (defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor)
Accuracy of family members identified will be defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor.
Measured: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Secondary outcomes (1)
Family and provider communication (Communication of family health history with family members and health care providers)
Communication of family health history with family members and health care providers.
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startNov 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Catharine Wang, Boston University
- Investigators
- Catharine Wang, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344433
- Sponsor's protocol ID
- H-32767
- Other IDs
- 1R01HG007746-01
- Acronym
- VICKY
- Status last verified
- Oct 2019
- First submitted
- 12 Jan 2015
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Paasche-Orlow MK, Bowen DJ, Cabral H, Winter MR, Norkunas Cunningham T, Trevino-Talbot M, Toledo DM, Cortes DE, Campion M, Bickmore T. Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial. Patient Educ Couns. 2021 May;104(5):979-988. doi: 10.1016/j.pec.2021.02.034. Epub 2021 Feb 18.
PubMed 33750594
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY
- ClinicalTrials.gov ID
- NCT02344433
- Acronym / sponsor ID
- VICKY / H-32767
- Conditions
- Heart Disease, Stroke, Diabetes, Cancer
- Keywords
- Family health history, Genetic literacy, Health literacy, Relational agent, Common chronic conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Northeastern University, National Human Genome Research Institute (NHGRI)
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Jan 2015 (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.
A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VICKY | Experimental | Behavioral: VICKYRelational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History). |
| MFHP | Active comparator | Behavioral: MFHPOnline family health history collection tool (MFHP: My Family Health Portrait). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21 years of age or older;
- current Boston Medical Center patient - must have an upcoming returning patient appointment at Boston Medical Center or affiliated clinic within 3 months of recruitment;
- speaks English and/or Spanish.
Key exclusion criteria (3 listed)
- Under 21 years of age;
- not a current patient of Boston Medical Center or affiliated clinic;
- unable to speak English and/or Spanish.
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 |
|---|---|---|
| VICKYRelational agent/virtual counselor | Behavioural | VICKY |
| MFHPUS Surgeon General's family history tool | Behavioural | MFHP |
Primary outcome
Accuracy of health conditions id'd (interview w/ genetic counselor gold standard. health conditions id'd by VICKY or MFHP id'd by genetic counselor (true +) divided by health conditions captured by genetic counselor (false - plus true +)
Time frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Sensitivity will be calculated using an interview with a genetic counselor as the gold standard. Sensitivity will be defined as the health conditions identified by the family health history tool (VICKY or MFHP) that were also identified by the genetic counselor (true positive) divided by the health conditions not captured by the tool but captured by the genetic counselor (false negatives) plus the true positives.
Accuracy of family members identified (defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor)
Time frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Accuracy of family members identified will be defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor.
1 secondary outcome
Family and provider communication (Communication of family health history with family members and health care providers)
Time frame: Baseline and 3 month follow-up
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 24 Oct 2019.
- Derived from this study: PubMed 33750594Wang C, Paasche-Orlow MK, Bowen DJ, Cabral H, Winter MR, Norkunas Cunningham T, Trevino-Talbot M, Toledo DM, Cortes DE, Campion M, Bickmore T. Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial. Patient Educ Couns. 2021 May;104(5):979-988. doi: 10.1016/j.pec.2021.02.034. Epub 2021 Feb 18.
- Individual participant dataSharing planned: No
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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.
Catharine Wang principal investigator
Boston University
Questions about this trial
What is this clinical trial studying?
A study testing VICKY and MFHP in people with Heart Disease and Stroke, run by Boston University.
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 3 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Accuracy of health conditions id'd (interview w/ genetic counselor gold standard. health conditions id'd by VICKY or MFHP id'd by genetic counselor (true +) divided by health conditions captured by genetic counselor (false - plus true +) (time frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344433, which also lists 1 linked publication.
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 24 Oct 2019.