Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.

Official Title
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A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial

Conditions
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Alzheimer Disease, Genetic Predisposition to Disease

Intervention / Treatment
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* Other: Two-way videoconference remote genetic counseling
* Other: Telephone remote genetic counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible to participate in the Generation Study Ability to provide consent Ability to communicate and hear in English Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone<br>Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. | Other: Telephone remote genetic counseling<br> <br> |
| Experimental: Videoconference<br>Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. | Other: Two-way videoconference remote genetic counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale |  | 2-7 days | 
| Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale |  | 2-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Disease-specific distress as measured by the Impact of Events Scale |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Depression as measured by the GDS Short Form |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI): |  | 2-7 days, 6 weeks, 6 months, 12 months | 
| Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale |  | 2-7 days, 6 weeks, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Counseling, Genetic