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Completed

NCT Number: NCT02978729

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible to participate in the Generation Study
  • Ability to provide consent
  • Ability to communicate and hear in English

Exclusion criteria

-

Treatment and study plan

Two-way videoconference remote genetic counseling

Other

Telephone remote genetic counseling

Other

Primary outcomes

  1. Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale

    Time frame: 2-7 days

  2. Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale

    Time frame: 2-7 days

Secondary outcomes

  1. Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  2. Disease-specific distress as measured by the Impact of Events Scale

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  3. Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  4. Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  5. Depression as measured by the GDS Short Form

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  6. Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

  7. Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale

    Time frame: 2-7 days, 6 weeks, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: CONNECT4APOE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2016
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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