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Telegenetics for Female My Life Our Future Participants: A Randomized Control Trial

Investigators: Michelle Witkop, DNP, FNP-BC; Joanna Davis, MD; Amber Federizo, APRN, FNP-BC; Sarah E. Ryan, MS, LCGC; Maria Santaella, MSN, RN-BC, CPHON; Matthew Shullick, MPH, MHSA, MS, FNP-C; Cynthia Nichols, PhD

 

Status: open and enrolling

This study’s goal is to show the value of genetic counseling in providing sensitive My Life, Our Future (MLOF) genotyping (genetic testing) results. Genetic counselors are professionals who have specialized education in medical genetics and counseling to guide and support patients looking for more information about their genetic health.

This approach will be compared to how treatment centers currently give that information. How Centers give that information to MLOF participants is dramatically different across the United States (US). Comparisons will be made between a.) how well the participant understands the information given from a genetic counselor vs. a healthcare provider (any type), b.) whether a participant develops a plan of care, and c.) how satisfied the participant and the genetic counselor are with using telemedicine for genetic counseling.

Everyone will receive genetic counseling using telemedicine, a video chat between the participant and the genetic counselor using either a smartphone or a computer through a HIPAA secure compliant link. All information produced by the genetic counseling session will remain confidential. Only the participant will receive the information, nothing will go to their health insurance carrier or their health care provider. To help measure changes between the two groups, health behaviors will be assessed through secure online surveys.

Study participants will be randomly sorted into two groups. One group will receive free, confidential telegenetic counseling by a licensed HTC genetic counselor shortly after enrollment in the study. The other group will receive their genotyping (genetic testing) results in the way they normally would through their HTC (standard care).  After the women in the second group have completed the six-month study they will be offered the same telegenetic counseling.

 

Objectives:

  • Demonstrate and describe telegenetics (the use of telemedicine for genetic counseling) as a model of care to increase access to specialty genetic counseling within the bleeding disorders community
  • Determine if those who have access to a specialized genetic counselor demonstrate incremental improvements in knowledge when compared to those with no previous specialized genetic counseling
  • Determine if the specialized genetics counseling session has an impact on the management plan of care
  • Describe satisfaction with telegenetics counseling from the point of view of the patient and genetic counselor

 

Eligibility criteria:

To participate in the study, you must:

  • Be a female who has undergone genotyping (genetic testing) through the MLOF program
  • Received your MLOF genotyping (genetic testing) result
  • Have not received any genetic counseling.
    • May have gotten results of genotyping (genetic testing) from a healthcare provider, “told” what the report means, or had the report sent to you. This is different from seeing a specialized staff member that is called a “genetic counselor” and would spend an hour or more to discuss your history and talk about what the changes in your genes mean to you and any children you have.
  • Be of any age but females between the ages 12-18 will have genetic counseling done with parent/guardian participation. Under the age of 12, the counseling will be provided to a parent/guardian.
  • Have access to a smartphone or computer with a camera and internet connection
  • Able to read and speak English (translation services are not available)

 

This study has been approved by the Munson Medical Center's Institutional Review Board (IRB) and is solely supported by NHF.

Eligible women will be enrolled on a first-come, first serve basis. Participation will be limited by available resources and timeframe.

To participate in this study, please call Maria Santaella at (347) 918-6608 or email her at msantaella@hemophilia.org

For other questions/inquiries, email mwitkop@hemophilia.org