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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02978729
Acronym
CONNECT4APOE
Enrollment
613
Registered
2016-12-01
Start date
2016-08-31
Completion date
2019-07-11
Last updated
2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Genetic Predisposition to Disease

Keywords

Telemedicine, Counseling, Genetic

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.

Interventions

OTHERTwo-way videoconference remote genetic counseling
OTHERTelephone remote genetic counseling

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frame
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale2-7 days
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale2-7 days

Secondary

MeasureTime frame
Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms2-7 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) scale2-7 days, 6 weeks, 6 months, 12 months
Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale2-7 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 Scale2-7 days, 6 weeks, 6 months, 12 months
Depression as measured by the GDS Short Form2-7 days, 6 weeks, 6 months, 12 months
Disease-specific distress as measured by the Impact of Events Scale2-7 days, 6 weeks, 6 months, 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026