Assessment of the Educational Experiences for Patients Newly Diagnosed With Nephrotic Syndrome

Overview

The purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to participate in this study.

Full Title of Study: “Assessment of the Educational Experience for Patients With Newly Diagnosed Nephrotic Syndrome”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2014

Detailed Description

The survey included questions addressing the following areas: 1.) Information that is important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time frame required to acquire confidence in the management of Nephrotic Syndrome. 4.) Disease-specific information such as diagnosis, length of disease duration, medications used, need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as race/ethnicity and educational background. The survey data is stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.

Arms, Groups and Cohorts

  • NEPTUNE contact registry patients
    • Patients and caregivers will be recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. Analysis of the one-time online questionnaire will be done in collaboration with investigators from the NEPTUNE Consortium.

Clinical Trial Outcome Measures

Primary Measures

  • Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients
    • Time Frame: 1 year after the study is closed to enrollment
    • The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.

Secondary Measures

  • Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome
    • Time Frame: 1 year after the study is closed to enrollment
    • The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.

Participating in This Clinical Trial

Inclusion Criteria

Patient and Patient Caregiver:

  • 18 years or older – English literate – History of Nephrotic Syndrome > 3 months or caregiver of a child diagnosed with Nephrotic Syndrome > 3 months prior to enrollment – Informed Consent Healthcare Worker Inclusion Criteria:

  • Age > 18 years – English literate – Provides medical care for children or adults with Nephrotic Syndrome – Informed Consent Exclusion Criteria:

  • Inability to provide informed consent and complete survey – Other criteria as specified by Consortium and based on the data we collect in the Contact Registry

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of South Florida
  • Collaborator
    • Maine Medical Partners
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marie Tanzer, MD, Study Chair, Maine Medical Partners
    • Debbie Gipson, MD, Study Chair, C.S. Mott Children’s Hospital

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