The KidneyCARE (Community Access to Research Equity) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorTufts Medical Center
About this trial
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 KidneyCARE Study (kidneycarestudy.org). The KidneyCARE Study 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 Study 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 Study is all online and can be accessed any time of day at kidneycarestudy.org. Participation is voluntary and free.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with any stage of CKD, including kidney transplant recipients and patients on dialysis.
Age 18 years and above.
Willing to participate in the Study and complete the informed consent form and assent form (where applicable).
Able to participate in this Study, which initially will be in English and then eventually expand to other languages.
Disqualifiers
Patient not diagnosed with CKD
Age below 18 years
Not willing to participate in the Study as well as unwilling to complete the informed consent form
Trial population
Patient recruitment targets two audiences: general public and closed systems. The general public is reached through a comprehensive outreach program that includes other NKF programs, local NKF field offices, participants from clinical trials for kidney disease treatments, referrals from other Network's participants, professional societies and patient advocacy groups, and a direct public relations campaign. The closed systems include health systems, academic medical centers, testing laboratories, or rare kidney disease groups. Here, patients will be recruited using the methods available at each organization (e.g., e-blasts, newsletters, provider/care manager recommendation, MyChart messages).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study - registry
Other interventionThe Study 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.
Treatment groups
50,000 Participants
are divided into 1 treatment groupGroup A: People with chronic kidney disease1 intervention
Trial outcomes
Primary outcomes
1
Total number of enrolled participants
Reach 10,000 enrolled participants
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
National Kidney Foundation, United States
Collaborator
Source ClinicalTrials.gov