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

Alzheimer Disease Clinical Trial

— CONNECT4APOE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978729
• Other study ID #: 824225
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 11, 2019

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Alzheimer Disease
• Disease Susceptibility
• Genetic Predisposition to Disease

Intervention

Other:
• Two-way videoconference remote genetic counseling

• Telephone remote genetic counseling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale		2-7 days
Primary	Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale		2-7 days
Secondary	Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale		2-7 days, 6 weeks, 6 months, 12 months
Secondary	Disease-specific distress as measured by the Impact of Events Scale		2-7 days, 6 weeks, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	Depression as measured by the GDS Short Form		2-7 days, 6 weeks, 6 months, 12 months
Secondary	Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):		2-7 days, 6 weeks, 6 months, 12 months
Secondary	Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale		2-7 days, 6 weeks, 6 months, 12 months