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Chronic kidney disease (CKD) is a serious and growing public health problem. The purpose of this study is to find out if an educational worksheet, called the Encounter Decision Intervention (EDI), combined with health coaching helps CKD patients improve their blood pressure and other health outcomes. The research team hypothesizes that the intervention group will have greater improvement in CKD outcomes than the control group.
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). Additionally, we have increased the window tolerance for data collection by a few months for greater flexibility. We also collect survey data from patients' providers to assess their perception of the intervention's usefulness after patients complete their follow-up study visits. The provider survey data collection will occur up to one year, with an anticipated 100 participating providers. In addition to the 320 patients already enrolled, the study is expected to include a total of 420 participants.
Age
21 - 85 years
Sex
ALL
Healthy Volunteers
No
University of Michigan / Domino's Farms
Ann Arbor, Michigan, United States
University of Michigan / Briarwood Family Medicine
Ann Arbor, Michigan, United States
University of Michigan / Brighton Health Center
Brighton, Michigan, United States
University of Michigan / Canton Health Center
Canton, Michigan, United States
University of Michigan / Chelsea Health Center
Chelsea, Michigan, United States
University Health Center - GMAP/Gen Med
Detroit, Michigan, United States
University Health Center - Med Peds
Detroit, Michigan, United States
University of Michigan / Dexter Health Center
Dexter, Michigan, United States
University of Michigan / Livonia Health Center
Livonia, Michigan, United States
University of Michigan / Northville Health Center
Northville, Michigan, United States
Start Date
February 4, 2020
Primary Completion Date
February 1, 2025
Completion Date
December 3, 2025
Last Updated
February 10, 2026
320
ACTUAL participants
Control-EDI
BEHAVIORAL
Intervention-EDI and health coaching
BEHAVIORAL
Lead Sponsor
University of Michigan
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07094906