Assessment of Quality of Life in Pediatric Patients

With Legg-Calve-Perthes Disease (LCPD)


Clinical Trial

Offered by: Nemours
Location: Delaware Valley

Trial Name

Assessment of Quality of Life in Pediatric Patients With Legg-Calve-Perthes Disease (LCPD)

What is the trial about?

The purpose of this study is to determine if the PROMIS questionnaire is able to report the health-related quality of life in patients with Perthes Disease. This study will also determine whether or not patients with more advanced Perthes have decreased health-related quality of life.

Who can participate?

Patients under the age of 18 years of age who have been diagnosed with Perthes disease can be in the study.

What is involved?

Only one visit is required that can last from 15-30 minutes. The choice of location can either be in the clinic or at another location that has computer access.

At the time that you and your child have accepted to participate in the study, the research procedures can begin.

PROMIS Questionnaire – Health Related Quality of Life survey

You and your child will be given instructions to either access the PROMIS questionnaire from the clinic or from home. The location is up to you to decide.  You will have a username and password that is unique to your child.

A. PROMIS Questionnaire – patient over 8 years of age

If you decide to take part in the study, you or your child have the option of filling out the online survey today while you are at the doctor's office or taking the survey on a computer at home. The questionnaire will take about 15-20 minutes to complete. If you or your child would like to complete the questionnaire in the doctor’s office, a member of the research team will give you or your child access to the study website and will be available to answer any questions that arise during completion of the survey. If you or your child decides to complete the survey from a computer at home, you will be given written instructions to access the survey on any computer. You may review the instructions and ask questions prior to leaving the doctor's office. A phone number will be available for you to call the research team if any questions come up when you or your child are completing the survey at home. Finally, if you or your child chooses to fill out the questionnaire at home and you have not completed it after two weeks, your doctor or a member of the study team will call you and remind you to complete the questionnaire. They will also address any additional concerns or questions that you may have.

B. PROMIS questionnaire – patient under 8 years of age

If you decide to take part in the study, you will have the option of filling out the online survey today while you are at the doctor's office or taking the survey on a computer at home. The questionnaire will take about 15-20 minutes to complete. If you would like to complete the questionnaire in the doctor’s office, a member of the research team will give you access to the study website and will be available to answer any questions that arise during completion of the survey. If you decide to complete the survey from a computer at home, you will be given written instructions to access the survey on any computer. You may review the instructions and ask questions prior to leaving the doctor's office. A phone number will be available for you to call the research team if any questions come up when you are completing the survey at home. Finally, if you choose to fill out the questionnaire at home and you have not completed it after two weeks, your doctor or a member of the study team will call you and remind you to complete the questionnaire. They will also address any additional concerns or questions that you may have.

Clinical Information

The investigators will review the medical chart related to information regarding the diagnosis of Perthes for your child. This information will include the date of birth, visit dates, clinical examination, conservative treatment, surgical treatment, and medical imaging. The information collected will be entered onto a form. A subject identification number that is unique to your child will be written on the form. The form will be scanned and sent by email to the investigators at Columbia. The email will be encrypted.

Contact Nemours Clinical Trials

Trial Name:
Assessment of Quality of Life in Pediatric Patients With Legg-Calve-Perthes Disease (LCPD)

IRB: 509605

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org