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

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

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.

Study Overview

• Status: Completed
• Conditions: Nephrotic Syndrome

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.

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Data Management and Coordinating Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: C.S. Mott Children's Hospital; Maine Medical Partners
• Investigators: Study Chair: Marie Tanzer, MD, Maine Medical Partners; Study Chair: Debbie Gipson, MD, C.S. Mott Children's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: 6802