Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2
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|ClinicalTrials.gov Identifier: NCT02793063|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment|
|Osteogenesis Imperfecta Brittle Bone Disorders||Other: Web-based Survey|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Rare Diseases Clinical Research Network Brittle Bone Disorders Consortium Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 10, 2016|
|Actual Study Completion Date :||August 10, 2016|
BBD Consortium Contact Registrants
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.
Other: Web-based Survey
This study will occur online. Participants will be asked to complete multiple surveys one time. Participants may receive study reminder emails to complete surveys. Participants will be able to complete the surveys all at once or in multiple sessions. Participants will have approximately 3 months to complete the surveys after consenting.
- Validated Computer Adaptive Testing (CAT) PROMIS instruments [ Time Frame: 3 months ]An online assessment will be used to obtain responses for each instrument. Scores for each are norm-based with a mean of 50 and standard deviation of 10 based upon the general population. Calibration of the standard error (SE) surrounding the reported score is possible. Default setting of 0.30 will be used for standard error with the minimum number of questions per item of 4 and maximum number of questions 8, using the computer adapted testing structure of the PROMIS instruments. Lower maximum number than the default settings will be used to avoid too many questions being given to a respondent when they do not report a diminished quality of life on any dimension. With these settings, survey respondents will be administered an average of 4-5 items per instrument and the testing among patients with OI indicate that the whole assessment will typically take 15-30 minutes in most instances.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793063
|United States, Florida|
|University of South Florida, Health Informatics Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jeffrey Krischer, Ph.D.||University of South Florida|
|Principal Investigator:||Laura Tosi, M.D.||Children's National Research Institute|
|Study Chair:||Jeffrey Krischer, Ph.D.||University of South Florida|
|Study Chair:||Laura Tois, M.D.||Children's National Research Institute|