Controlling Hypertension Through Education and Coaching in Kidney Disease (CHECK-D)

University of Michigan

Status: Invitation-only

Conditions: Chronic Kidney Disease, Stage 4 (Severe); Chronic Kidney Diseases; Chronic Disease; Chronic Kidney Disease Stage 5; Chronic Kidney Disease, Stage 3 (Moderate)

Treatments: Behavioral: Intervention-EDI and health coaching; Behavioral: Control-EDI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04087798

HUM00136011

R01DK115844-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control-EDI

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention-EDI and health coaching