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| ID | Type | Description | Link |
|---|---|---|---|
| PCPM | Other Identifier | Penn Center for Precision Medicine |
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The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Virtual/Telephone | Experimental | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. |
|
| Virtual/Virtual | Active Comparator | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMAGINE-PD | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Genetics Knowledge | Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge) | 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) | 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) | 3 months after disclosure counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic Counseling Satisfaction (Pre-Test) | Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction) | Immediately after pre-test education/counseling |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F Tropea, DO | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Parkinsons Disease and Movement Disorders Center | Philadelphia | Pennsylvania | 19107 | United States |
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.
Upon request by collaborators and upon publication of scientific manuscripts.
Approval by the BRAC
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A factorial design schema was used for group randomization based on pre-test education or counseling (i.e., IMAGINE-PD or Virtual) and post-test counseling (i.e. Telephone or Virtual) modalities. All randomized participants were included in an intention-to-treat (ITT) analysis. A per protocol (PP) analysis defined a subset of participants with data for all 3 primary outcome variables (i.e., completed visit 3 for genetic counseling satisfaction, genetics knowledge, and test-related distress).
Eligible participants from UPenn's Parkinson's Disease and Movement Disorders Center's Molecular Integration in Neurological Diagnosis (MIND) Initiative who were 21 years old or older, willing to complete confirmatory genetic testing, willing to learn their genetic test results, and had access to a telephone, computer, and videoconferencing device. Key exclusion criteria were prior genetic counseling for PD, prior diagnosis of dementia, or scored <21 on the Montreal Cognitive Assessment (MoCA).
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| ID | Title | Description |
|---|---|---|
| FG000 | IMAGINE-PD/Virtual | Pre-test genetic education 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: 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 counseling: The virtual visits will be conducted by a certified genetic counselor to provide all counseling in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans or Zoom). |
| FG001 | IMAGINE-PD/Telephone | 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. IMAGINE-PD: 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. Telephone genetic counseling: 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. |
| FG002 | Virtual/Telephone | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. Virtual genetic counseling: 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 PennChart/EPIC electronic medical record dashboard. Telephone genetic counseling: 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. |
| FG003 | Virtual/Virtual | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. Virtual genetic counseling: 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, in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans or Zoom). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IMAGINE-PD/Virtual | 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. IMAGINE-PD: 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 counseling: 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 or Zoom). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Genetics Knowledge | Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge) | Posted | Median | Inter-Quartile Range | score on a scale | 4 weeks after pre-testing education/counseling |
|
Adverse events (AEs) were collected at each study visit up to 6 months post disclosure, coinciding with the final study visit.
AEs reviewed during the study include death during the study period or medical event during a study visit. Study outcomes were evaluated to determine AEs including number of unique individuals (not unique events) above cutpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint; GDS: Above 5 point cutpoint; STAI: Above 40 on either sub scale).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMAGINE-PD/Virtual | 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. IMAGINE-PD: 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 counseling: 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 PennChart/EPIC electronic medical record dashboard. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impact of Events IES-R | Psychiatric disorders | Systematic Assessment | Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (IES-R: above 33 point cutpoint). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Paul, Genetic Counselor | UPenn | 215-490-5816 | rachel.paul3@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2020 | Feb 19, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2020 | Jan 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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|
| Virtual genetic counseling | Other | 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 counseling | Other | 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. |
|
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
| 3 months after disclosure counseling |
| Depression | Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression) | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 6 months after disclosure counseling |
| Lost to Follow-up |
|
| Death |
|
| Adverse Event |
|
| Ineligible after randomization |
|
| Moved to a different group |
|
| BG001 | IMAGINE-PD/Telephone | 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. IMAGINE-PD: 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. Telephone genetic counseling: 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. |
| BG002 | Virtual/Telephone | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. Virtual genetic counseling: 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 or Zoom). Telephone genetic counseling: 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. |
| BG003 | Virtual/Virtual | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. Virtual genetic counseling: 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 or Zoom). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PD family history | Count of Participants | Participants |
|
| Genetic Screening Result | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Disease Duration | Median | Inter-Quartile Range | years |
|
| Baseline Genetics Knowledge (GKS) total | 20 question, true/false questionnaire, self-administered. Novel instrument adapted from questionnaires previously administered in PD research studies. Topics include general and PD-specific genetics knowledge, genetic testing attitudes and beliefs, interest in genetic testing and counseling. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Montreal Cognitive Assessment (MoCA) total | The Montreal Cognitive Assessment is a 30-point, validated cognitive screening tool. Test is administered by coordinator. Scores are added for a total (score range 0-30). Higher scores associate with better cognitive performance. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Geriatric Depression Scale (GDS) total | The Geriatric Depression Scale (short version) is a 15-item, "Yes/No", validated, self-report measure of depression in older adults. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline State-Trait Anxiety Scale (STAI)-state | The State-Trait Anxiety Inventory is a 40 item, 4-point, well-validated self-report scale measuring aspects of both state- and trait-anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline State Trait Anxiety Scale (STAI)-trait | The State-Trait Anxiety Inventory is a 40 item, 4-point, well-validated self-report scale measuring aspects of both state- and trait-anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Parkinsons Disease Questionnaire-39 (PDQ-39) item summary index (PDQ-39) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | IMAGINE-PD/Telephone | 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. IMAGINE-PD: 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. Telephone genetic counseling: 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. |
| OG002 | Virtual/Telephone | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. Virtual genetic counseling: 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 PennChart/EPIC electronic medical record dashboard. Telephone genetic counseling: 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. |
| OG003 | Virtual/Virtual | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. Virtual genetic counseling: 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, in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans or Zoom). |
|
|
| Primary | Genetic Counseling Satisfaction (Post-Test) | Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction) | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after disclosure counseling |
|
|
|
| Primary | Test-Related Distress | Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after disclosure counseling |
|
|
|
| Secondary | Genetic Counseling Satisfaction (Pre-Test) | Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction) | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after pre-test education/counseling |
|
|
|
| Secondary | Depression | Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression) | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after disclosure counseling |
|
|
|
| Secondary | Depression | Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression) | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months after disclosure counseling |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after disclosure counseling |
|
|
|
| Secondary | Test-Related Distress | Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress) | Posted | Median | Inter-Quartile Range | score on a scale | 6 months after disclosure counseling |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 83 |
| 94 |
| EG001 | IMAGINE-PD/Telephone | 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. IMAGINE-PD: 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. Telephone genetic counseling: 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. | 1 | 91 | 0 | 91 | 82 | 91 |
| EG002 | Virtual/Telephone | Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. Virtual genetic counseling: 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 PennChart/EPIC electronic medical record dashboard. Telephone genetic counseling: 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. | 1 | 92 | 0 | 92 | 78 | 92 |
| EG003 | Virtual/Virtual | Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. Virtual genetic counseling: 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 PennChart/EPIC electronic medical record dashboard. | 0 | 93 | 0 | 93 | 83 | 93 |
|
| Depression | Psychiatric disorders | Systematic Assessment | Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (GDS: Above 5 point cutpoint) |
|
| Anxiety | Psychiatric disorders | Systematic Assessment | Unique individuals (not unique events) above outpoint for psychiatric outcomes during any study visit (STAI: Above 40 on either sub scale) |
|
| Medical event unrelated to study | General disorders | Non-systematic Assessment | Medical event during study visit that was unrelated to study |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |