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

Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190955
• Other study ID #: 6802
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: July 11, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	University of South Florida Data Management and Coordinating Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	C.S. Mott Children's Hospital, Maine Medical Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients	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.	1 year after the study is closed to enrollment	No
Secondary	Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome	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.	1 year after the study is closed to enrollment	No

External Links

•   NEPTUNE Clinical Research Consortium