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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale [ Time Frame: 2-7 days ]
  • Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale [ Time Frame: 2-7 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale [ Time Frame: 2-7 days, 6 weeks, 6 months, 12 months ]
  • Disease-specific distress as measured by the Impact of Events Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2-7 days, 6 weeks, 6 months, 12 months ]
  • Depression as measured by the GDS Short Form [ Time Frame: 2-7 days, 6 weeks, 6 months, 12 months ]
  • Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI): [ Time Frame: 2-7 days, 6 weeks, 6 months, 12 months ]
  • Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale [ Time Frame: 2-7 days, 6 weeks, 6 months, 12 months ]


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: November 7, 2016
Date Started: August 2016
Date Completion:
Last Updated: November 28, 2016
Last Verified: November 2016