Trial Outcomes & Findings for GEnetic Counseling Through Virtual Visits in Parkinson's Disease (NCT NCT04527146)

NCT ID: NCT04527146

Last Updated: 2025-03-11

Results Overview

Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 370 participants
• Primary outcome timeframe: 4 weeks after pre-testing education/counseling
• Results posted on: 2025-03-11

Participant Flow

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).

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).

Participant milestones

Measure	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).	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.	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.	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).
Overall Study STARTED	94	91	92	93
Overall Study COMPLETED	61	63	65	60
Overall Study NOT COMPLETED	33	28	27	33

Reasons for withdrawal

Measure	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).	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.	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.	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).
Overall Study Withdrawal by Subject	12	15	7	16
Overall Study Lost to Follow-up	13	9	16	13
Overall Study Death	0	1	1	0
Overall Study Adverse Event	0	0	1	0
Overall Study Ineligible after randomization	2	0	2	2
Overall Study Moved to a different group	6	3	0	2

Baseline Characteristics

GEnetic Counseling Through Virtual Visits in Parkinson's Disease

Baseline characteristics by cohort

Measure	IMAGINE-PD/Virtual n=94 Participants 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).	IMAGINE-PD/Telephone n=91 Participants 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.	Virtual/Telephone n=92 Participants 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.	Virtual/Virtual n=93 Participants 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).	Total n=370 Participants Total of all reporting groups
Age, Continuous	70 years n=5 Participants	68 years n=7 Participants	68 years n=5 Participants	70 years n=4 Participants	69 years n=21 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	32 Participants n=7 Participants	29 Participants n=5 Participants	26 Participants n=4 Participants	131 Participants n=21 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	59 Participants n=7 Participants	63 Participants n=5 Participants	67 Participants n=4 Participants	239 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	88 Participants n=7 Participants	88 Participants n=5 Participants	85 Participants n=4 Participants	349 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment United States	94 participants n=5 Participants	91 participants n=7 Participants	92 participants n=5 Participants	93 participants n=4 Participants	370 participants n=21 Participants
PD family history Yes	33 Participants n=5 Participants	42 Participants n=7 Participants	38 Participants n=5 Participants	37 Participants n=4 Participants	150 Participants n=21 Participants
PD family history No/Unk/Missing	61 Participants n=5 Participants	49 Participants n=7 Participants	54 Participants n=5 Participants	56 Participants n=4 Participants	220 Participants n=21 Participants
Genetic Screening Result Negative	80 Participants n=5 Participants	70 Participants n=7 Participants	71 Participants n=5 Participants	82 Participants n=4 Participants	303 Participants n=21 Participants
Genetic Screening Result Positive	14 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	11 Participants n=4 Participants	67 Participants n=21 Participants
Education < HS	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Education HS	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants
Education Associate	12 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	15 Participants n=4 Participants	58 Participants n=21 Participants
Education Bachelor	34 Participants n=5 Participants	34 Participants n=7 Participants	30 Participants n=5 Participants	28 Participants n=4 Participants	126 Participants n=21 Participants
Education Graduate	44 Participants n=5 Participants	34 Participants n=7 Participants	39 Participants n=5 Participants	39 Participants n=4 Participants	156 Participants n=21 Participants
Education Missing	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Disease Duration	6 years n=5 Participants	6 years n=7 Participants	7 years n=5 Participants	7 years n=4 Participants	7 years n=21 Participants
Baseline Genetics Knowledge (GKS) total	16 units on a scale n=5 Participants	17 units on a scale n=7 Participants	17 units on a scale n=5 Participants	16 units on a scale n=4 Participants	17 units on a scale n=21 Participants
Baseline Montreal Cognitive Assessment (MoCA) total	27 units on a scale n=5 Participants	27 units on a scale n=7 Participants	27 units on a scale n=5 Participants	26 units on a scale n=4 Participants	27 units on a scale n=21 Participants
Baseline Geriatric Depression Scale (GDS) total	3 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants	3 units on a scale n=4 Participants	3 units on a scale n=21 Participants
Baseline State-Trait Anxiety Scale (STAI)-state	36 units on a scale n=5 Participants	37 units on a scale n=7 Participants	36 units on a scale n=5 Participants	36 units on a scale n=4 Participants	36 units on a scale n=21 Participants
Baseline State Trait Anxiety Scale (STAI)-trait	35 units on a scale n=5 Participants	34 units on a scale n=7 Participants	34 units on a scale n=5 Participants	35 units on a scale n=4 Participants	34 units on a scale n=21 Participants
Baseline Parkinsons Disease Questionnaire-39 (PDQ-39) item summary index (PDQ-39)	20 units on a scale n=5 Participants	18 units on a scale n=7 Participants	18 units on a scale n=5 Participants	19 units on a scale n=4 Participants	19 units on a scale n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks after pre-testing education/counseling

Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)

Outcome measures

Measure	IMAGINE-PD/Virtual n=94 Participants 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).	IMAGINE-PD/Telephone n=91 Participants 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.	Virtual/Telephone n=92 Participants 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.	Virtual/Virtual n=93 Participants 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).
Genetics Knowledge	16 score on a scale Interval 14.0 to 18.0	17 score on a scale Interval 15.0 to 19.0	17 score on a scale Interval 15.0 to 18.0	16 score on a scale Interval 15.0 to 18.0

PRIMARY outcome

Timeframe: Immediately after disclosure counseling

Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)

Outcome measures

Measure	IMAGINE-PD/Virtual n=76 Participants 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).	IMAGINE-PD/Telephone n=74 Participants 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.	Virtual/Telephone n=70 Participants 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.	Virtual/Virtual n=67 Participants 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).
Genetic Counseling Satisfaction (Post-Test)	24 score on a scale Interval 18.0 to 26.75	25 score on a scale Interval 20.5 to 27.0	25 score on a scale Interval 21.75 to 28.0	26 score on a scale Interval 21.0 to 28.0

PRIMARY outcome

Timeframe: 3 months after disclosure counseling

Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)

Outcome measures

Measure	IMAGINE-PD/Virtual n=72 Participants 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).	IMAGINE-PD/Telephone n=69 Participants 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.	Virtual/Telephone n=73 Participants 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.	Virtual/Virtual n=68 Participants 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).
Test-Related Distress	0 score on a scale Interval 0.0 to 4.75	1 score on a scale Interval 0.0 to 9.0	0 score on a scale Interval 0.0 to 6.0	0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Immediately after pre-test education/counseling

Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)

Outcome measures

Measure	IMAGINE-PD/Virtual n=93 Participants 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).	IMAGINE-PD/Telephone n=90 Participants 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.	Virtual/Telephone n=89 Participants 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.	Virtual/Virtual n=88 Participants 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).
Genetic Counseling Satisfaction (Pre-Test)	22 score on a scale Interval 20.0 to 26.0	23 score on a scale Interval 21.0 to 25.8	24 score on a scale Interval 21.0 to 27.0	25 score on a scale Interval 22.0 to 27.2

SECONDARY outcome

Timeframe: 3 months after disclosure counseling

Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)

Outcome measures

Measure	IMAGINE-PD/Virtual n=68 Participants 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).	IMAGINE-PD/Telephone n=67 Participants 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.	Virtual/Telephone n=72 Participants 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.	Virtual/Virtual n=64 Participants 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).
Depression	3 score on a scale Interval 1.0 to 5.0	3 score on a scale Interval 1.0 to 4.0	2.5 score on a scale Interval 1.0 to 6.0	3 score on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 6 months after disclosure counseling

Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)

Outcome measures

Measure	IMAGINE-PD/Virtual n=62 Participants 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).	IMAGINE-PD/Telephone n=65 Participants 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.	Virtual/Telephone n=70 Participants 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.	Virtual/Virtual n=61 Participants 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).
Depression	3 score on a scale Interval 1.0 to 5.25	3 score on a scale Interval 1.0 to 4.0	3 score on a scale Interval 1.0 to 6.0	3 score on a scale Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: 3 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=68 Participants 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).	IMAGINE-PD/Telephone n=67 Participants 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.	Virtual/Telephone n=72 Participants 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.	Virtual/Virtual n=62 Participants 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).
State-Trait Anxiety Index-State Score	35 score on a scale Interval 24.25 to 44.75	36 score on a scale Interval 25.0 to 41.0	35 score on a scale Interval 28.0 to 47.75	36 score on a scale Interval 26.0 to 44.25

SECONDARY outcome

Timeframe: 6 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=61 Participants 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).	IMAGINE-PD/Telephone n=63 Participants 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.	Virtual/Telephone n=66 Participants 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.	Virtual/Virtual n=59 Participants 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).
State-Trait Anxiety Index -State Score	35 score on a scale Interval 27.0 to 42.5	36 score on a scale Interval 29.0 to 44.0	34.5 score on a scale Interval 27.5 to 49.0	36 score on a scale Interval 23.0 to 45.0

SECONDARY outcome

Timeframe: 3 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=68 Participants 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).	IMAGINE-PD/Telephone n=67 Participants 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.	Virtual/Telephone n=72 Participants 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.	Virtual/Virtual n=62 Participants 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).
State-Trait Anxiety Index -Trait Score	34 score on a scale Interval 26.0 to 44.0	33 score on a scale Interval 28.0 to 41.0	38 score on a scale Interval 26.0 to 47.0	34 score on a scale Interval 27.0 to 42.25

SECONDARY outcome

Timeframe: 6 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=61 Participants 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).	IMAGINE-PD/Telephone n=63 Participants 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.	Virtual/Telephone n=66 Participants 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.	Virtual/Virtual n=59 Participants 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).
State-Trait Anxiety Index -Trait Score	34 score on a scale Interval 26.0 to 42.0	34 score on a scale Interval 27.0 to 43.0	35 score on a scale Interval 24.0 to 45.0	35 score on a scale Interval 26.0 to 43.0

SECONDARY outcome

Timeframe: 3 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=68 Participants 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).	IMAGINE-PD/Telephone n=67 Participants 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.	Virtual/Telephone n=72 Participants 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.	Virtual/Virtual n=61 Participants 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).
Quality of Life in Parkinson's Disease	21.41 score on a scale Interval 10.74 to 36.76	15.83 score on a scale Interval 9.948 to 25.26	16.56 score on a scale Interval 6.315 to 32.83	18.44 score on a scale Interval 11.74 to 28.28

SECONDARY outcome

Timeframe: 6 months after disclosure counseling

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.

Outcome measures

Measure	IMAGINE-PD/Virtual n=61 Participants 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).	IMAGINE-PD/Telephone n=63 Participants 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.	Virtual/Telephone n=66 Participants 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.	Virtual/Virtual n=59 Participants 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).
Quality of Life in Parkinson's Disease	20.99 score on a scale Interval 11.35 to 34.19	15.31 score on a scale Interval 7.344 to 28.7	17.79 score on a scale Interval 7.5 to 33.82	19.22 score on a scale Interval 11.09 to 34.69

SECONDARY outcome

Timeframe: 6 months after disclosure counseling

Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)

Outcome measures

Measure	IMAGINE-PD/Virtual n=68 Participants 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).	IMAGINE-PD/Telephone n=67 Participants 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.	Virtual/Telephone n=73 Participants 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.	Virtual/Virtual n=67 Participants 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).
Test-Related Distress	0 score on a scale Interval 0.0 to 4.0	0 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 6.0	0 score on a scale Interval 0.0 to 5.0

Adverse Events

IMAGINE-PD/Virtual

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

IMAGINE-PD/Telephone

Serious events: 0 serious events

Other events: 82 other events

Deaths: 1 deaths

Virtual/Telephone

Serious events: 0 serious events

Other events: 78 other events

Deaths: 1 deaths

Virtual/Virtual

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IMAGINE-PD/Virtual n=94 participants at risk 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.	IMAGINE-PD/Telephone n=91 participants at risk 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.	Virtual/Telephone n=92 participants at risk 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.	Virtual/Virtual n=93 participants at risk 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.
Psychiatric disorders Impact of Events IES-R	5.3% 5/94 • 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).	7.7% 7/91 • 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).	2.2% 2/92 • 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).	6.5% 6/93 • 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).
Psychiatric disorders Depression	35.1% 33/94 • 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).	28.6% 26/91 • 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).	31.5% 29/92 • 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).	29.0% 27/93 • 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).
Psychiatric disorders Anxiety	47.9% 45/94 • 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).	53.8% 49/91 • 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).	50.0% 46/92 • 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).	53.8% 50/93 • 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).
General disorders Medical event unrelated to study	0.00% 0/94 • 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).	0.00% 0/91 • 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).	1.1% 1/92 • 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).	0.00% 0/93 • 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).

Additional Information

Rachel Paul, Genetic Counselor

UPenn

Phone: 215-490-5816

Email: rachel.paul3@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place