Clinical trial NCT02190955: Assessment of the Educational Experiences for Patients Newly Diagnosed With Nephrotic Syndrome
Official title: Assessment of the Educational Experience for Patients With Newly Diagnosed Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Maine Medical Partners
name: C.S. Mott Children's Hospital
First posted: 2014-07-15
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients
timeFrame: 1 year after the study is closed to enrollment
Secondary outcomes:
measure: Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome
timeFrame: 1 year after the study is closed to enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management and Coordinating Center
state: Florida
Study officials:
affiliation: Maine Medical Partners
name: Marie Tanzer, MD
role: STUDY_CHAIR
affiliation: C.S. Mott Children's Hospital
name: Debbie Gipson, MD
role: STUDY_CHAIR
References: