Back to resultsTelephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial (CONNECT4APOE)
Primary Purpose
Alzheimer Disease, Genetic Predisposition to Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Two-way videoconference remote genetic counseling
Telephone remote genetic counseling
Sponsored by
About this trial
This is an interventional health services research trial for Alzheimer Disease focused on measuring Telemedicine, Counseling, Genetic
Eligibility Criteria
Inclusion Criteria:
- Eligible to participate in the Generation Study
- Ability to provide consent
- Ability to communicate and hear in English
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Telephone
Videoconference
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
Secondary Outcome Measures
Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
Disease-specific distress as measured by the Impact of Events Scale
Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms
Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale
Depression as measured by the GDS Short Form
Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
Full Information
NCT ID
NCT02978729
First Posted
November 7, 2016
Last Updated
November 18, 2020
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02978729
Brief Title
Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Acronym
CONNECT4APOE
Official Title
A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Genetic Predisposition to Disease
Keywords
Telemedicine, Counseling, Genetic
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
613 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Videoconference
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Two-way videoconference remote genetic counseling
Intervention Type
Other
Intervention Name(s)
Telephone remote genetic counseling
Primary Outcome Measure Information:
Title
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
Time Frame
2-7 days
Title
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
Time Frame
2-7 days
Secondary Outcome Measure Information:
Title
Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
Time Frame
2-7 days, 6 weeks, 6 months, 12 months
Title
Disease-specific distress as measured by the Impact of Events Scale
Time Frame
2-7 days, 6 weeks, 6 months, 12 months
Title
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
Title
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
Title
Depression as measured by the GDS Short Form
Time Frame
2-7 days, 6 weeks, 6 months, 12 months
Title
Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
Time Frame
2-7 days, 6 weeks, 6 months, 12 months
Title
Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
Time Frame
2-7 days, 6 weeks, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eligible to participate in the Generation Study
Ability to provide consent
Ability to communicate and hear in English
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela R Bradbury, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
We'll reach out to this number within 24 hrs