Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2

University of South Florida

Status: Completed

Conditions: Osteogenesis Imperfecta; Brittle Bone Disorders

Treatments: Other: Web-based Survey

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT02793063

U01TR001263 (U.S. NIH Grant/Contract)

BBD7702

Details and patient eligibility

About

The purpose of this study is to explore the patient perspective of disease burden in Osteogenesis Imperfecta (OI). Participants will complete a web-based survey of questions which are usually administered within the Patient-Reported Outcome Measurement Information System (PROMIS) and provide feedback regarding the appropriateness of the questions for someone with OI.

Full description

Participants will be recruited through the RDCRN BBD Contact Registry. An email invitation will be sent to all RDCRN BBD Contact Registry participants that meet the inclusion criteria to complete the online PROMIS CAT instruments. The email invitation will contain a link to the informed consent form. Once participants have consented to the study, they will have access to the online instruments. Follow-up emails will be sent to participants that have not completed any of the instruments. Reminder emails will be sent to participants with partially completed instruments.

Data will be collected and stored by the RDCRN DMCC at USF.

Data from patients co-enrolled in the "Longitudinal Study of Osteogenesis Imperfecta" and the BBD RDCRN Contact Registry will be linked and compared. Additional disease specific information will be collected by the survey (e.g., information on OI type and diagnosis, height, number of fractures, concurrent medication use, utilization of any mobility aid, hearing aid, or other device that they may use.

Enrollment: 300 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrollment in the RDCRN BBD Contact Registry English speaking Age 2 to adult

Exclusion criteria

• Inability to provide informed consent Inability to complete instruments

Trial design

300 participants in 1 patient group

BBD Consortium Contact Registrants

Description:

Osteogenesis Imperfecta patients who have self-registered at the Brittle Bone Disorders Consortium (BBD) Consortium Contact Registry, a web-based contact registry developed and supported by the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Consortium (RDCRN), located at the University of South Florida.

Treatment:

Other: Web-based Survey