Controlling Hypertension Through Education and Coaching in Kidney Disease

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.

Conditions

• Chronic Kidney Diseases
• Chronic Disease
• Chronic Kidney Disease, Stage 3 (Moderate)
• Chronic Kidney Disease, Stage 4 (Severe)
• Chronic Kidney Disease Stage 5
• Hypertension

Interventions

BEHAVIORAL

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).

BEHAVIORAL

Intervention-EDI

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.

BEHAVIORAL

Health coaching

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).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Julie Wright-Nunes, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-04

Primary Completion

2025-02-01

Completion

2025-12-03

Countries

• United States

Study Locations