Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Disease
  • Chronic Kidney Disease Stage 5
  • Chronic Kidney Disease, Stage 3 (Moderate)
  • Chronic Kidney Disease, Stage 4 (Severe)
  • Chronic Kidney Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Cluster Randomized DesignMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 21 years and 85 years
Gender
Both males and females

Description

Patients that meet eligibility criteria and are seen in a clinic assigned to the control group will be given a Control-Encounter Decision Intervention (Control-EDI) about kidney disease in general (not tailored to the patient) by their primary care provider. Eligible patients that agree to participa...

Patients that meet eligibility criteria and are seen in a clinic assigned to the control group will be given a Control-Encounter Decision Intervention (Control-EDI) about kidney disease in general (not tailored to the patient) by their primary care provider. Eligible patients that agree to participate and give consent will complete enrollment, 1, 6, and 12 month follow-up visits. Eligible patients that are seen in a clinic assigned to the intervention group will be given a personalized Intervention-EDI by their primary care provider. Following this, eligible patients that agree to participate and give consent will complete the enrollment visit, and have a baseline call with a health coach. In addition to the 1, 6, 12 month follow-up visits these patients will also have approximately 4-6 phone calls with the health coach between the baseline visit and 11 months after enrollment. In both groups the study team will be collecting medical information and assessments regarding their health; blood sample and urine samples at baseline and 12 months; approximately 4-6 phone calls; as well as surveys at various time points. In order to reduce in-person human subject activity due to the Coronavirus disease 2019 (COVID-19) pandemic, participants in both groups receive an at home blood pressure monitor so that systolic- & diastolic-BP data can be collected at all 4 time points (baseline, 1, 6, 12 months).

Tracking Information

NCT #
NCT04087798
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Julie Wright, MD University of Michigan