A National Registry for People With All Stages of Kidney Disease: the National Kidney Foundation (NKF) Patient Network

Sponsor

Tufts Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05497518

Collaborator

National Kidney Foundation (Other)

50,000

Enrollment

Location

588

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

For chronic kidney disease (CKD), there is a lack of unique and powerful platform for patient engagement, research studies and public health advocacy work. The National kidney Foundation (NKF) launched the first nationwide registry for people at all stages and types of CKD, including people on dialysis and kidney transplant recipients, called the NKF Patient Network (NKFPatientNetwork.org). The NKF Patient Network is a non-interventional research study which means participants will not have to take medications or do any additional tests to participate. They are simply asked to share some personal and health information, and their experiences with their disease through a secure portal. The Network also collaborates with health systems to obtain additional electronic health records (EHR) data. This unique combination of data collected will address the gap of individualized educational resources and will enhance clinical research, clinical care, and health policy decisions to be centered on the patient. The NKF also partnered with the Alport Syndrome Foundation (ASF) on the NKF Patient Network - Alport Syndrome, a registry expansion that will contribute to research and treatments for Alport syndrome. The NKF Patient Network is all online and can be accessed any time of day at NKFPatientNetwork.org. Participation is voluntary and free.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease Dialysis Kidney Transplant Alport Syndrome	Other: Observational study - registry

Detailed Description

The NKF Patient Network is a longitudinal prospective and retrospective observational cohort study of patient-entered data that collaborates with health systems to obtain additional electronic health records (EHR) data. The NKF also partnered with the Alport Syndrome Foundation (ASF) on the NKF Patient Network - Alport Syndrome, a registry expansion that will contribute to research and treatments for Alport syndrome. The NKF Patient Network and the NKF Patient Network - Alport Syndrome are approved by the Tufts Health Sciences Institutional Review Board, which serves as the IRB of record for all U.S. sites. The NKF Patient Network will start patient recruitment outside of the U.S. in 2022. The first international country will be Canada. The University of Manitoba, Winnipeg, MB, Canada is the Coordinating Site for all Canadian sites.

Pulse Infoframe (Pulse) is the platform partner responsible for the development and implementation of the registry on their healthieTM 2.0 Amazon Web Services (AWS) Global Cloud platform and data management. All data collected through the NKF Patient Network is stored on the healthieTM 2.0 platform, a secure system that meets existing GDPR, HIPAA and other international established standards for privacy and security of health information. Several precautions are taken to assure the confidentiality of patients. Immediately after enrollment, each patient is assigned a GUID (Globally Unique IDentifier) and a study specific identifier, which is used to identify the patient's database records. GUID is generated randomly and systemically and does not include other identifiers. The database employs multiple security features to limit access to any PHI to authorized study team members only. The computerized database tags all person identifying information (PII) and PHI data and not permit the viewing of such data except by authorized parties. Strict control over data viewing based on role-based permissions is enforced.

De-identified aggregate data is available for analysis to the NKF and the partners of the NKF Patient Network via analytic portals, dashboards, and/or subscription reports depending on contractual agreements. The individual site's data will be segregated from the rest of the registry, but the de-identified aggregate data can still be included in the overall registry's dashboard, reports, and analytics. Research proposals by partners and outside investigators that require advanced statistical analysis for publications in peer-reviewed journals, abstracts, and/or posters must be submitted and approved according to the Data Use and Publications policy. The Data Coordinating Center (DCC) or Pulse, depending on the request, conduct the statistical analyses for all approved research proposals.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

National Kidney Foundation Patient Network

Actual Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Feb 24, 2070

Anticipated Study Completion Date :

Feb 24, 2070

Arms and Interventions

Arm	Intervention/Treatment
People with chronic kidney disease No interventions will be administered as part of this registry.	Other: Observational study - registry The Network is a longitudinal observational cohort study that collaborates with health systems to obtain both electronic healthcare records (EHR) and patient-entered data. Eligible people with a diagnosis of chronic kidney disease at any stage, age 18 years and above, are identified through EHR data review, referral by a provider, or are recruited through the NKF's outreach campaign. Patients self-enroll into the online registry and share their experiences and health data through a secure portal where they can also find education, tips, and support. Research partners can view aggregate data through a collaboration portal.

Arm

Intervention/Treatment

People with chronic kidney disease

No interventions will be administered as part of this registry.

Other: Observational study - registry

The Network is a longitudinal observational cohort study that collaborates with health systems to obtain both electronic healthcare records (EHR) and patient-entered data. Eligible people with a diagnosis of chronic kidney disease at any stage, age 18 years and above, are identified through EHR data review, referral by a provider, or are recruited through the NKF's outreach campaign. Patients self-enroll into the online registry and share their experiences and health data through a secure portal where they can also find education, tips, and support. Research partners can view aggregate data through a collaboration portal.

Outcome Measures

Primary Outcome Measures

Total number of enrolled participants [5 years]
Reach 10,000 enrolled participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with any stage of CKD, including kidney transplant recipients and patients on dialysis.
Age 18 years and above. Patients with Alport syndrome who decide to register to the NKF Patient Network - Alport Syndrome can be of any age.
Willing to participate in the NKF Patient Network and complete the informed consent form and assent form (where applicable).
Able to participate in this NKF Patient Network, which initially will be in English and then eventually expand to other languages.
Patients affiliated with Geisinger Health System must have given their consent to Geisinger Health System IRB to be contacted for research projects.

Exclusion Criteria:

Patient not diagnosed with CKD
Age below 18 years (only for patients without a diagnosis of Alport syndrome)
Not willing to participate in the NKF Patient Network as well as unwilling to complete the informed consent form