Clinical trial NCT04087798: Controlling Hypertension Through Education and Coaching in Kidney Disease
Official title: Controlling Hypertension Through Education and Coaching in Kidney Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Kidney Diseases
Chronic Disease
Chronic Kidney Disease, Stage 3 (Moderate)
Chronic Kidney Disease, Stage 4 (Severe)
Chronic Kidney Disease Stage 5
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-09-12
Enrollment: 420
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Design
Primary purpose: SUPPORTIVE_CARE

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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure between baseline and 12 months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in Diastolic Blood Pressure between baseline and 12 months
timeFrame: Baseline, 12 months
measure: Slope of systolic BP between baseline and 12 months using all available BP values
timeFrame: Baseline up to 12 months
measure: Slope of diastolic BP between baseline and 12 months using all available BP values
timeFrame: Baseline up to 12 months
measure: CKD knowledge measured by the Kidney Knowledge Survey (KiKS)
timeFrame: Baseline up to 12 months
measure: Medication Adherence Self-Efficacy Scale-Revised (MASES-R)
timeFrame: Baseline up to 12 months
measure: Morisky Medication Adherence Scale (MMAS - 8)
timeFrame: Baseline up to 12 months
measure: Visit Time with provider
timeFrame: Enrollment visit (baseline)
measure: Total time in clinic
timeFrame: Enrollment visit (baseline)
measure: Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)
timeFrame: Baseline up to 12 months
measure: Satisfaction with CKD care based on Communication Assessment Tool (CAT)
timeFrame: Baseline up to 12 months
measure: Satisfaction with CKD care based on Consultation Care Measure (CCM)
timeFrame: Baseline up to 12 months
measure: Perceptions of health coaching for the intervention group
timeFrame: Baseline up to 12 months
measure: Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
timeFrame: Baseline up to 12 months
measure: Self-reported Blood Pressure-Related Behaviors Survey
timeFrame: Baseline up to 12 months
measure: Provider Adoption based on EMR query and patient survey
timeFrame: Baseline
measure: Provider Fidelity measured by EMR query
timeFrame: Baseline
measure: Provider Perception of Usefulness by provider survey
timeFrame: After all patient follow-ups, up to one year
measure: Change in serum creatinine
timeFrame: Baseline, 12 months
measure: Change in urine protein-creatinine ratio
timeFrame: Baseline, 12 months
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: Baseline, 12 months
measure: Change in EMR-recorded blood pressure between baseline and 12 months
timeFrame: Baseline up to 12 months
measure: Change in study visit blood pressure supplemented with EMR blood pressure if missing
timeFrame: Baseline up to 12 months
measure: Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan / Domino's Farms
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan / Briarwood Family Medicine
state: Michigan
city: Brighton
country: United States
facility: University of Michigan / Brighton Health Center
state: Michigan
city: Canton
country: United States
facility: University of Michigan / Canton Health Center
state: Michigan
city: Chelsea
country: United States
facility: University of Michigan / Chelsea Health Center
state: Michigan
city: Detroit
country: United States
facility: University Health Center - GMAP/Gen Med
state: Michigan
city: Detroit
country: United States
facility: University Health Center - Med Peds
state: Michigan
city: Dexter
country: United States
facility: University of Michigan / Dexter Health Center
state: Michigan
city: Livonia
country: United States
facility: University of Michigan / Livonia Health Center
state: Michigan
city: Northville
country: United States
facility: University of Michigan / Northville Health Center
state: Michigan
city: Ypsilanti
country: United States
facility: University of Michigan / Ypsilanti Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: