Parkinson DiseaseGET-VIRTUALNCT04527146
GEnetic Counseling Through Virtual Visits in Parkinson's Disease
A study testing IMAGINE-PD, Virtual genetic counseling and Telephone genetic counseling in people with Parkinson Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- IMAGINE-PD, Virtual genetic counseling and Telephone genetic counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provision of signed and dated informed consent form
- Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
- Male or female, over the age of 21.
- English Speaking
Who cannot join
- Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
- Montreal Cognitive Assessment (MoCA) < 21, or a prior diagnosis of dementia during the screening phase
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Parkinsons Disease and Movement Disorders Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
Read the detailed description
This research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with Parkinson's disease. Participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods. In both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence. The primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale. The purpose is to develop effective and scalable approaches to genetic counseling. This work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.
- Conditions
- Parkinson Disease
- Being tested
- IMAGINE-PD, Virtual genetic counseling, Telephone genetic counseling
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAGINE-PDOther
The Interactive, Multimedia Approach to Genetic Counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) is a novel, interactive, web-based, audiovisual, self-guided, genetic counseling tool in the development phase. Essential genetic counseling themes, outlined by a senior certified clinical genetics counselor in accordance with national guidelines, are presented in a web-based format, utilizing videos, text, pictures, and audio. Participants can interact with IMAGINE-PD at their own pace, with the ability to move backward and forward, repeat sections, and have the ability to submit questions to the genetic counselor via e-mail.
Virtual genetic counselingOther
The virtual visits will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors. The counseling visit will be conducted in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans) within the Penn Chart/Epic electronic medical record dashboard.
Telephone genetic counselingOther
The telephone counseling will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors.
| Study group | Role | What they receive |
|---|---|---|
| IMAGINE-PD/Virtual | Experimental | Pre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via virtual visit with a genetic counselor. Receives: Other: IMAGINE-PD; Other: Virtual genetic counseling |
| IMAGINE-PD/Telephone | Experimental | Pre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via telephone with a genetic counselor. Receives: Other: IMAGINE-PD; Other: Telephone genetic counseling |
| Virtual/Telephone | Experimental | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. Receives: Other: Virtual genetic counseling; Other: Telephone genetic counseling |
| Virtual/Virtual | Active comparator | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. Receives: Other: Virtual genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetics Knowledge
Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
Measured: 4 weeks after pre-testing education/counseling
Genetic Counseling Satisfaction (Post-Test)
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Measured: Immediately after disclosure counseling
Test-Related Distress
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Measured: 3 months after disclosure counseling
Secondary outcomes (10)
Genetic Counseling Satisfaction (Pre-Test)
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Measured: Immediately after pre-test education/counseling
Depression
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Measured: 3 months after disclosure counseling
Depression
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Measured: 6 months after disclosure counseling
State-Trait Anxiety Index-State Score
State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 of the total 40 items included in the State Score are predefined according to the validated scale.
Measured: 3 months after disclosure counseling
State-Trait Anxiety Index -State Score
State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.
Measured: 6 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.
Measured: 3 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.
Measured: 6 months after disclosure counseling
Quality of Life in Parkinson's Disease
Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.
Measured: 3 months after disclosure counseling
Quality of Life in Parkinson's Disease
Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.
Measured: 6 months after disclosure counseling
Test-Related Distress
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Measured: 6 months after disclosure counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Jan 2021
- Primary completion15 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Enrolled participants will be randomized into one of 4 groups based on pre- and post-genetic test counseling: (1)IMAGINE-PD/Virtual, (2)IMAGINE-PD/Telephone, (3)Virtual/Virtual, and (4)Virtual/Telephone.
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Tropea, DO, University of Pennsylvania
- Investigators
- Thomas F Tropea, DO, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527146
- Sponsor's protocol ID
- 843748
- Other IDs
- PCPM
- Acronym
- GET-VIRTUAL
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2020
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and isolated DNA samples will be stored for future research purposes for an indefinite amount of time. Individual participant data (IPD) may be shared with other research, academic, and medical institutions, other researchers, drug and device companies, biotechnology companies and others. In the event of such a collaboration, no personally identifying information will be shared. Potential collaborators may apply with a description of the proposed project. This application is then evaluated by a Biospecimen Review Access Committee (BRAC). Only projects deemed to have scientific or clinical merit will be considered eligible to receive samples or information, from which personally identifying information will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04527146
- Acronym / sponsor ID
- GET-VIRTUAL / 843748
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
Detailed description
This research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with Parkinson's disease. Participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods. In both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence. The primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale. The purpose is to develop effective and scalable approaches to genetic counseling. This work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Enrolled participants will be randomized into one of 4 groups based on pre- and post-genetic test counseling: (1)IMAGINE-PD/Virtual, (2)IMAGINE-PD/Telephone, (3)Virtual/Virtual, and (4)Virtual/Telephone.
| Arm | Type | Receives |
|---|---|---|
| IMAGINE-PD/Virtual | Experimental | Other: IMAGINE-PD, Other: Virtual genetic counselingPre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via virtual visit with a genetic counselor. |
| IMAGINE-PD/Telephone | Experimental | Other: IMAGINE-PD, Other: Telephone genetic counselingPre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via telephone with a genetic counselor. |
| Virtual/Telephone | Experimental | Other: Virtual genetic counseling, Other: Telephone genetic counselingPre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. |
| Virtual/Virtual | Active comparator | Other: Virtual genetic counselingPre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
- Male or female, over the age of 21.
- English Speaking
Key exclusion criteria (2 listed)
- Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
- Montreal Cognitive Assessment (MoCA) < 21, or a prior diagnosis of dementia during the screening phase
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 |
|---|---|---|
| IMAGINE-PDThe Interactive, Multimedia Approach to Genetic Counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) is a novel, interactive, web-based, audiovisual, self-guided, genetic counseling tool in the development phase. Essential genetic counseling themes, outlined by a senior certified clinical genetics counselor in accordance with national guidelines, are presented in a web-based format, utilizing videos, text, pictures, and audio. Participants can interact with IMAGINE-PD at their own pace, with the ability to move backward and forward, repeat sections, and have the ability to submit questions to the genetic counselor via e-mail. | Other | IMAGINE-PD/Telephone, IMAGINE-PD/Virtual |
| Virtual genetic counselingThe virtual visits will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors. The counseling visit will be conducted in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans) within the Penn Chart/Epic electronic medical record dashboard. | Other | IMAGINE-PD/Virtual, Virtual/Telephone, Virtual/Virtual |
| Telephone genetic counselingThe telephone counseling will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors. | Other | IMAGINE-PD/Telephone, Virtual/Telephone |
Primary outcome
Genetics Knowledge
Time frame: 4 weeks after pre-testing education/counseling
Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
Genetic Counseling Satisfaction (Post-Test)
Time frame: Immediately after disclosure counseling
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Test-Related Distress
Time frame: 3 months after disclosure counseling
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
10 secondary outcomes
Genetic Counseling Satisfaction (Pre-Test)
Time frame: Immediately after pre-test education/counseling
Depression
Time frame: 3 months after disclosure counseling
Depression
Time frame: 6 months after disclosure counseling
State-Trait Anxiety Index-State Score
Time frame: 3 months after disclosure counseling
State-Trait Anxiety Index -State Score
Time frame: 6 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
Time frame: 3 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
Time frame: 6 months after disclosure counseling
Quality of Life in Parkinson's Disease
Time frame: 3 months after disclosure counseling
Quality of Life in Parkinson's Disease
Time frame: 6 months after disclosure counseling
Test-Related Distress
Time frame: 6 months after disclosure counseling
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All data and isolated DNA samples will be stored for future research purposes for an indefinite amount of time. Individual participant data (IPD) may be shared with other research, academic, and medical institutions, other researchers, drug and device companies, biotechnology companies and others. In the event of such a collaboration, no personally identifying information will be shared. Potential collaborators may apply with a description of the proposed project. This application is then evaluated by a Biospecimen Review Access Committee (BRAC). Only projects deemed to have scientific or clinical merit will be considered eligible to receive samples or information, from which personally identifying information will be removed.
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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.
Thomas F Tropea, DO principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMAGINE-PD, Virtual genetic counseling and Telephone genetic counseling in people with Parkinson Disease, run by University of Pennsylvania 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 4 inclusion and 2 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 11 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Genetics Knowledge (time frame: 4 weeks after pre-testing education/counseling). The study lists 3 primary outcomes in all. 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 11 Mar 2025.