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

NCT ID: NCT02978729

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-07-11

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.

Detailed Description

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Conditions

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Alzheimer Disease Genetic Predisposition to Disease

Keywords

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Telemedicine Counseling, Genetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Telephone remote genetic counseling

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Two-way videoconference remote genetic counseling

Intervention Type OTHER

Interventions

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Two-way videoconference remote genetic counseling

Intervention Type OTHER

Telephone remote genetic counseling

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela R Bradbury, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Other Identifiers

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824225

Identifier Type: -

Identifier Source: org_study_id