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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Genetic Predisposition to Disease
• Interventions: Other: Telephone remote genetic counseling; Other: Two-way videoconference remote genetic counseling

• Registration Number: NCT02978729
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Primary Completion: 2019-07-11
• Study Completion: 2019-07-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

1. Eligible to participate in the Generation Study
2. Ability to provide consent
3. Ability to communicate and hear in English

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone	Telephone remote genetic counseling	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.
Videoconference	Two-way videoconference remote genetic counseling	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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