Controlling Hypertension Through Education and Coaching in Kidney Disease
NCT ID: NCT04087798
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
420 participants
INTERVENTIONAL
2020-02-04
2025-12-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Eligible patients enrolled from the control group clinics will be given a Control-EDI which has information about kidney disease in general (not tailored to the patient) during their clinic visit.
Control-EDI
Patients in the control group will receive Control-EDI from their primary care provider during clinic visit. Subsequent patient CKD education and follow-up will be provider dependent. Patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
Intervention
Eligible patients enrolled from the intervention group clinics will be given an Intervention-EDI which has personalized information about kidney disease. There will be space on this for the provider to type in any goals or key points they want the patient to remember. Additionally, patients in this group will also receive health coaching.
Intervention-EDI and health coaching
Patients in the intervention group will receive a personalized Intervention-EDI from their primary care provider during visit, which will include their most recent BP, their urine protein level and most recent eGFR. There is also a space for their provider to type in a sentence about specific goals for the patient.
Health coaches will conduct a baseline call and 4-6 coaching calls, based on patient's needs, over an 11-month period. There are 4 topic areas related to blood pressure and CKD that will be the focus of the calls. Coaches will also have pre-determined and vetted educational resources to provide patients if needed. Additionally, patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
Interventions
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Control-EDI
Patients in the control group will receive Control-EDI from their primary care provider during clinic visit. Subsequent patient CKD education and follow-up will be provider dependent. Patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
Intervention-EDI and health coaching
Patients in the intervention group will receive a personalized Intervention-EDI from their primary care provider during visit, which will include their most recent BP, their urine protein level and most recent eGFR. There is also a space for their provider to type in a sentence about specific goals for the patient.
Health coaches will conduct a baseline call and 4-6 coaching calls, based on patient's needs, over an 11-month period. There are 4 topic areas related to blood pressure and CKD that will be the focus of the calls. Coaches will also have pre-determined and vetted educational resources to provide patients if needed. Additionally, patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aware of CKD diagnosis
* Has diagnosis of hypertension documented in medical record and most recent Blood Pressure (BP) within the last year meets criteria of uncontrolled hypertension (≥140 mmHg, and/or a diastolic blood pressure ≥90 mmHg noted in an ambulatory care setting within the past one year)
* Estimated glomerular filtration rate (eGFR) of \<60 within the last 18 months documented in the medical record
Exclusion Criteria
* Previous kidney transplant
* Pregnant (indicated by medical record or if patient self-identifies as pregnant)
* Has cognitive, language, or vision impairment(s) that would prohibit participating in education, taking surveys, or participating in coaching activities
* Has terminal illness
21 Years
85 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Responsible Party
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Julie Wright-Nunes
Associate Professor Department of Internal Medicine
Principal Investigators
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Julie Wright, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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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
University of Michigan / Ypsilanti Health Center
Ypsilanti, Michigan, United States
Countries
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References
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Wright Nunes JA, Resnicow K, Richardson C, Levine D, Kerr E, Saran R, Gillespie B, Bragg-Gresham J, Delacroix EL, Considine S, Fan A, Ellies T, Garcia-Guzman L, Grzyb K, Klinkman M, Rockwell P, Billi J, Martin C, Collier K, Parker-Featherstone E, Bryant N, Seitz M, Lukela J, Brinley FJ, Fagerlin A. Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. BMJ Open. 2023 Aug 1;13(8):e071318. doi: 10.1136/bmjopen-2022-071318.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HUM00136011
Identifier Type: -
Identifier Source: org_study_id
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