Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn about participant and parent/guardian experiences and perceptions while they take part in a research study, particularly the Fontan Udenafil Exercise Longitudinal (FUEL) and FUEL Open Label Extension (OLE) studies. We will use their responses to survey questions to identify factors that could positively affect participation in future pediatric research studies.
What is the Pediatric Heart Network (PHN)?
This is a Pediatric Heart Network (PHN) research study. The PHN is a group of hospitals in the US and Canada that conducts research studies in children with heart disease and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Who can participate?
Teens and young adults with Fontan who are participating in the FUEL study, and their parents/guardians, may be able to participate.
What will happen in the study?
Consent for this study will include participation in both the FUEL and FUEL OLE studies.
FUEL and/or FUEL OLE Teen and Young Adult Participants:
Teen/young adult FUEL participants will be asked to complete a survey at their 6-month visit.
Participants from FUEL who go on to enroll in the FUEL OLE study will also be asked to complete a survey at their 12-month study visit.
If participants choose not to participate in the FUEL OLE, they may still participate in the 6-month FUEL survey and then be finished with this study.
In addition, some FUEL and FUEL OLE teen/young adult participants may be asked to take part in an interview. An interviewer will ask questions to better understand each person’s viewpoints and experiences of participation. The interview may be recorded and will take up to 30-45 minutes.
One or both parents/guardians will receive a survey at their child’s 6-month FUEL study visit. Parents/guardians will be asked to complete and return the survey(s) in sealed envelopes before leaving Cincinnati Children’s.
Parents/guardians of participants that also enroll in the FUEL OLE study will be asked to complete a survey at their child’s 12-month study visit. Study staff will make every effort to collect survey results from the same parent/guardian who completed the survey at the 6-month FUEL study visit.
If parents/guardians choose not to participate in FUEL OLE, they may still participate in the 6-month FUEL survey and then be finished with this study.
In all cases, parents/guardians should complete the survey independently to give researchers information from both the mother’s, father’s, or guardian’s point of view.
Families will be provided with return addressed stamped envelopes as needed. Reminder calls will be placed by study coordinators as needed to receive all outstanding surveys.
There will be no name included on any of the surveys. Once completed, the surveys are placed in an unidentifiable envelope and sealed to help maintain the confidentiality of the respondent.
You, as a parent/guardian or participant, will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
There are no direct benefits to individual participants or families. However, we hope the information learned from this study will help to improve the research experiences for participants in the future.
What are the bad things that can happen from this research?
Participants may feel uncomfortable responding to some of the statements/questions on the survey. There may be a small risk of loss of confidentiality.
All possible risks will be discussed with you/your child if you are interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participant and parent/guardian will each receive $20 per survey or interview completed.