Controlling Hypertension Through Education and Coaching in Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Controlling Hypertension Through Education and Coaching in Kidney Disease

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

Intervention / Treatment
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* Behavioral: Control-EDI
* Behavioral: Intervention-EDI and health coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Behavioral: Control-EDI<br>* 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).<br>* Other names: Control-Encounter Decision Intervention;|
| Experimental: Intervention<br>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. | Behavioral: Intervention-EDI and health coaching<br>* 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).<br>* Other names: Intervention-Encounter Decision Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure between baseline and 12 months | Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group. | Baseline, 12 months | 
| Slope of systolic BP between baseline and 12 months using all available BP values | BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group. | Baseline up to 12 months | 
| Slope of diastolic BP between baseline and 12 months using all available BP values | BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group. | Baseline up to 12 months | 
| CKD knowledge measured by the Kidney Knowledge Survey (KiKS) | 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. | Baseline up to 12 months | 
| Medication Adherence Self-Efficacy Scale-Revised (MASES-R) | 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. | Baseline up to 12 months | 
| Morisky Medication Adherence Scale (MMAS - 8) | 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. | Baseline up to 12 months | 
| Visit Time with provider | Length of time provider spends with the patient. This will be compared between the intervention group and control group. | Enrollment visit (baseline) | 
| Total time in clinic | Length of time between patient check-in and check-out. This will be compared between the intervention group and control group. | Enrollment visit (baseline) | 
| Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ) | 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. | Baseline up to 12 months | 
| Satisfaction with CKD care based on Communication Assessment Tool (CAT) | 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. | Baseline up to 12 months | 
| Satisfaction with CKD care based on Consultation Care Measure (CCM) | 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. | Baseline up to 12 months | 
| Perceptions of health coaching for the intervention group | 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. | Baseline up to 12 months | 
| Medication adherence from the electronic medical record (EMR) | The EMR will be reviewed to evaluate the patients medication refills for adherence. | Baseline up to 12 months | 
| Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS) | 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. | Baseline up to 12 months | 
| Self-reported Blood Pressure-Related Behaviors Survey | This is a 5-item survey about knowledge and behaviors regarding sodium in the diet. | Baseline up to 12 months | 
| Provider Adoption based on EMR query and patient survey | 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. | Baseline | 
| Provider Fidelity measured by EMR query | 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. | Baseline | 
| Provider Perception of Usefulness by provider survey | Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was. | Baseline up to 12 months | 
| Change in serum creatinine | Change in Serum Creatinine between baseline and 12-months | Baseline, 12 months | 
| Change in urine protein-creatinine ratio |  | Baseline, 12 months | 
| Change in estimated glomerular filtration rate (eGFR) |  | Baseline, 12 months |