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

NCT ID: NCT02793063

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-08-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteogenesis Imperfecta Brittle Bone Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Web-based Survey

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rare Diseases Clinical Research Network

NETWORK

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Krischer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Laura Tosi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Jeffrey Krischer, Ph.D.

Role: STUDY_CHAIR

University of South Florida

Laura Tois, M.D.

Role: STUDY_CHAIR

Children's National Research Institute

Locations

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University of South Florida, Health Informatics Institute

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18694191 (View on PubMed)

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.

Reference Type RESULT
PMID: 18804556 (View on PubMed)

Other Identifiers

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U01TR001263

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BBD7702

Identifier Type: -

Identifier Source: org_study_id

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