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Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial (CONNECT4APOE)

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ClinicalTrials.gov Identifier: NCT02978729
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Genetic Predisposition to Disease Other: Two-way videoconference remote genetic counseling Other: Telephone remote genetic counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Study Start Date : August 2016
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: Telephone remote genetic counseling
Experimental: 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.
Other: Two-way videoconference remote genetic counseling



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978729


Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Angela R Bradbury, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02978729    
Other Study ID Numbers: 824225
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Pennsylvania:
Telemedicine
Counseling, Genetic
Additional relevant MeSH terms:
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Alzheimer Disease
Disease Susceptibility
Genetic Predisposition to Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes