Back to resultsVirtual Visits for Results Disclosure
Primary Purpose
Genetic Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Visit
Sponsored by
About this trial
This is an interventional other trial for Genetic Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Undergoing genetic testing at BWH Cardiovascular Genetics clinic
Exclusion Criteria:
- Reside outside of Massachusetts
- Telephone or internet access unavailable
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Telephone Results Disclosure
Virtual Visit Results Disclosure
Arm Description
Outcomes
Primary Outcome Measures
Patient satisfaction
Web-based survey focused on patient comprehension and satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT03658382
First Posted
September 1, 2018
Last Updated
September 1, 2018
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03658382
Brief Title
Virtual Visits for Results Disclosure
Official Title
Randomized Controlled Trial Evaluating Patient Satisfaction With Virtual Visits for Results Disclosure in the Brigham and Women's Hospital Cardiovascular Genetics Program
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
As part of this study patients who have undergone genetic testing in the Brigham and Women's Hospital Cardiovascular Genetics program will be randomized to receive the results of their genetic testing either by telephone call or virtual visit. At the completion of the telephone call or virtual visit patients will receive a survey to assess their understanding of their results and their satisfaction with their care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Results Disclosure
Arm Type
No Intervention
Arm Title
Virtual Visit Results Disclosure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Virtual Visit
Intervention Description
Patients will receive the results of their genetic testing via a virtual visit.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Web-based survey focused on patient comprehension and satisfaction
Time Frame
within 7 days of results disclosure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Undergoing genetic testing at BWH Cardiovascular Genetics clinic
Exclusion Criteria:
Reside outside of Massachusetts
Telephone or internet access unavailable
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Learn more about this trial
Virtual Visits for Results Disclosure
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