NCT03658382

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 1, 2018

Last Update Submit

September 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Web-based survey focused on patient comprehension and satisfaction

    within 7 days of results disclosure

Study Arms (2)

Telephone Results Disclosure

NO INTERVENTION

Virtual Visit Results Disclosure

EXPERIMENTAL
Other: Virtual Visit

Interventions

Patients will receive the results of their genetic testing via a virtual visit.

Virtual Visit Results Disclosure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Undergoing genetic testing at BWH Cardiovascular Genetics clinic

You may not qualify if:

  • Reside outside of Massachusetts
  • Telephone or internet access unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Medicine Fellow

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 5, 2018

Study Start

September 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

No plan to share data