Controlling Hypertension Through Education and Coaching in Kidney Disease
CHECK-D
2 other identifiers
interventional
320
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
February 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2025
CompletedMarch 27, 2026
March 1, 2026
5 years
August 24, 2019
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Systolic Blood Pressure between baseline and 12 months
Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Baseline, 12 months
Secondary Outcomes (23)
Change in Diastolic Blood Pressure between baseline and 12 months
Baseline, 12 months
Slope of systolic BP between baseline and 12 months using all available BP values
Baseline up to 12 months
Slope of diastolic BP between baseline and 12 months using all available BP values
Baseline up to 12 months
CKD knowledge measured by the Kidney Knowledge Survey (KiKS)
Baseline up to 12 months
Medication Adherence Self-Efficacy Scale-Revised (MASES-R)
Baseline up to 12 months
- +18 more secondary outcomes
Study Arms (2)
Control: General Kidney Disease Education
ACTIVE COMPARATOREligible 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.
Intervention: Personalized Kidney Disease Education and Health Coaching
EXPERIMENTALEligible 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.
Interventions
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 estimated glomerular filtration rate (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).
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).
Eligibility Criteria
You may qualify if:
- Diagnosis of CKD stage 3, 4, or 5 documented in medical record
- 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
You may not qualify if:
- Currently on dialysis permanently (i.e. are considered "end-stage renal disease" and receiving dialysis)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Michigan / Domino's Farms
Ann Arbor, Michigan, 48105, United States
University of Michigan / Briarwood Family Medicine
Ann Arbor, Michigan, 48108, United States
University of Michigan / Brighton Health Center
Brighton, Michigan, 48116, United States
University of Michigan / Canton Health Center
Canton, Michigan, 48187, United States
University of Michigan / Chelsea Health Center
Chelsea, Michigan, 48118, United States
University Health Center - GMAP/Gen Med
Detroit, Michigan, 48201, United States
University Health Center - Med Peds
Detroit, Michigan, 48201, United States
University of Michigan / Dexter Health Center
Dexter, Michigan, 48130, United States
University of Michigan / Livonia Health Center
Livonia, Michigan, 48152, United States
University of Michigan / Northville Health Center
Northville, Michigan, 48168, United States
University of Michigan / Ypsilanti Health Center
Ypsilanti, Michigan, 48198, United States
Related Publications (1)
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.
PMID: 37527897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Wright-Nunes, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Department of Internal Medicine
Study Record Dates
First Submitted
August 24, 2019
First Posted
September 12, 2019
Study Start
February 4, 2020
Primary Completion
February 1, 2025
Study Completion
December 3, 2025
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share