Controlling Hypertension Through Education and Coaching in Kidney Disease

Not Applicable

Active, not recruiting

• Conditions: Chronic Kidney Diseases; Chronic Kidney Disease Stage 5; Chronic Disease; Chronic Kidney Disease, Stage 3 (Moderate); Chronic Kidney Disease, Stage 4 (Severe)
• Interventions: Behavioral: Control-EDI; Behavioral: Intervention-EDI and health coaching

• Registration Number: NCT04087798
• Lead Sponsor: University of Michigan

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.

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-24
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Study Start: 2020-02-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 320

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control-EDI	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.
Intervention	Intervention-EDI and health coaching	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.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure between baseline and 12 months	Baseline, 12 months	Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.

Secondary Outcome Measures

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

Trial Locations

Locations (11)

University of Michigan / Domino's Farms; 🇺🇸 Ann Arbor, Michigan, United States

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

University of Michigan / Brighton Health Center; 🇺🇸 Brighton, Michigan, United States

University of Michigan / Canton Health Center; 🇺🇸 Canton, Michigan, United States

University of Michigan / Chelsea Health Center; 🇺🇸 Chelsea, Michigan, United States

University Health Center - GMAP/Gen Med; 🇺🇸 Detroit, Michigan, United States

University Health Center - Med Peds; 🇺🇸 Detroit, Michigan, United States

University of Michigan / Dexter Health Center; 🇺🇸 Dexter, Michigan, United States

University of Michigan / Livonia Health Center; 🇺🇸 Livonia, Michigan, United States

University of Michigan / Northville Health Center; 🇺🇸 Northville, Michigan, United States

University of Michigan / Ypsilanti Health Center; 🇺🇸 Ypsilanti, Michigan, United States