Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial (CONNECT4APOE)

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Genetic Predisposition to Disease
• Intervention / Treatment: Other: Telephone remote genetic counseling; Other: Two-way videoconference remote genetic counseling

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telephone; 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
Experimental: Videoconference; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Angela R Bradbury, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Telemedicine; Counseling, Genetic
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 824225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO