- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793063
Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2
Rare Diseases Clinical Research Network Brittle Bone Disorders Consortium Osteogenesis Imperfecta (OI) Quality of Life Survey Pilot Project 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida, Health Informatics Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Validated Computer Adaptive Testing (CAT) PROMIS instruments
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
General Publications
- Richesson RL, Young K, Lloyd J, Adams T, Guillette H, Malloy J, Krischer JP. An automated communication system in a Contact Registry for persons with rare diseases: tools for retaining potential clinical research participants. AMIA Annu Symp Proc. 2007 Oct 11:1094.
- Richesson RL, Lee HS, Cuthbertson D, Lloyd J, Young K, Krischer JP. An automated communication system in a contact registry for persons with rare diseases: scalable tools for identifying and recruiting clinical research participants. Contemp Clin Trials. 2009 Jan;30(1):55-62. doi: 10.1016/j.cct.2008.09.002. Epub 2008 Sep 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBD7702
- U01TR001263 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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