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Completed

NCT Number: NCT04087798

Controlling Hypertension Through Education and Coaching in Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Stage 5 Chronic Kidney Disease, Stage 3 (Moderate) Chronic Kidney Disease, Stage 4 (Severe) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Hypertension Immune System Diseases Immunoproliferative Disorders Kidney Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan / Briarwood Family Medicine, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control-EDI

Behavioral

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

Behavioral

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 Coaching

Behavioral

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).

Primary outcomes

  1. Change in Systolic Blood Pressure between baseline and 12 months

    Time frame: Baseline, 12 months

    Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Secondary outcomes

  1. Change in Diastolic Blood Pressure between baseline and 12 months

    Time frame: Baseline, 12 months

    Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

  2. Slope of systolic BP between baseline and 12 months using all available BP values

    Time frame: Baseline up to 12 months

    BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

  3. Slope of diastolic BP between baseline and 12 months using all available BP values

    Time frame: Baseline up to 12 months

    BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.

  4. CKD knowledge measured by the Kidney Knowledge Survey (KiKS)

    Time frame: Baseline up to 12 months

    This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.

  5. Medication Adherence Self-Efficacy Scale-Revised (MASES-R)

    Time frame: Baseline up to 12 months

    This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.

  6. Morisky Medication Adherence Scale (MMAS - 8)

    Time frame: Baseline up to 12 months

    This scale is to quantify adherence to pharmacological treatments by 8 items. Levels of adherence are based on the following scores: <6 = low adherence; 6-<8 = medium adherence; 8 = high adherence.

  7. Visit Time with provider

    Time frame: Enrollment visit (baseline)

    Length of time provider spends with the patient. This will be compared between the intervention group and control group.

  8. Total time in clinic

    Time frame: Enrollment visit (baseline)

    Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.

  9. Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)

    Time frame: Baseline up to 12 months

    This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.

  10. Satisfaction with CKD care based on Communication Assessment Tool (CAT)

    Time frame: Baseline up to 12 months

    This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.

  11. Satisfaction with CKD care based on Consultation Care Measure (CCM)

    Time frame: Baseline up to 12 months

    This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree.

    Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.

  12. Perceptions of health coaching for the intervention group

    Time frame: Baseline up to 12 months

    During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.

  13. Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

    Time frame: Baseline up to 12 months

    This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.

  14. Self-reported Blood Pressure-Related Behaviors Survey

    Time frame: Baseline up to 12 months

    This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.

  15. Provider Adoption based on Electronic Medical Records (EMR) query and patient survey

    Time frame: Baseline

    Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.

  16. Provider Fidelity measured by EMR query

    Time frame: Baseline

    Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.

  17. Provider Perception of Usefulness by provider survey

    Time frame: After all patient follow-ups, up to one year

    Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.

  18. Change in serum creatinine

    Time frame: Baseline, 12 months

    Change in Serum Creatinine between baseline and 12-months

  19. Change in urine protein-creatinine ratio

    Time frame: Baseline, 12 months

    Change in urine protein-creatinine ratio between baseline and 12-months

  20. Change in estimated glomerular filtration rate (eGFR)

    Time frame: Baseline, 12 months

    Change in estimated glomerular filtration rate (eGFR) between baseline and 12-months

  21. Change in EMR-recorded blood pressure between baseline and 12 months

    Time frame: Baseline up to 12 months

    Changes in blood pressure recorded in the EMR from baseline to 12 months will be compared between the intervention group and control group

  22. Change in study visit blood pressure supplemented with EMR blood pressure if missing

    Time frame: Baseline up to 12 months

    Changes in blood pressure collected during study visits from baseline to 12 months will be compared between the intervention group and control group, with EMR data used to supplement missing values

  23. Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values

    Time frame: Baseline up to 12 months

    Changes in blood pressure from baseline to 12 months will be analyzed using a combined dataset that includes all available study visit and EMR blood pressure values

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Acronym: CHECK-D

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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