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

NCT02190955 | Completed

• 1 other identifier: 6802
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome

  1 year after the study is closed to enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and caregivers were 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. The Contact Registry was created to inform patients and/or parents of patients with Nephrotic Syndrome of clinical research studies. Health professionals, including pediatric and internal medicine nephrologists and nephrology nurses will be recruited from the 18 NEPTUNE study network sites.

You may qualify if:

• Patient and Patient Caregiver:
• 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
• Age \> 18 years
• English literate
• Provides medical care for children or adults with Nephrotic Syndrome
• Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Maine Medical Partners: collaborator
• C.S. Mott Children's Hospital: collaborator

Study Sites (1)

University of South Florida Data Management and Coordinating Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marie Tanzer, MD

  Maine Medical Partners

  STUDY CHAIR

• Debbie Gipson, MD

  C.S. Mott Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: July 15, 2014
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-06

Locations

US (1)