Controlling Hypertension Through Education and Coaching in Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 11
- 主要终点
- Change in Systolic Blood Pressure between baseline and 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
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.
干预措施: Control-EDI (Behavioral)
Intervention
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.
干预措施: Intervention-EDI and health coaching (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure between baseline and 12 months
时间窗: Baseline, 12 months
Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
次要结局
- Change in Diastolic Blood Pressure between baseline and 12 months(Baseline, 12 months)
- Slope of systolic BP between baseline and 12 months using all available BP values(Baseline up to 12 months)
- Slope of diastolic BP between baseline and 12 months using all available BP values(Baseline up to 12 months)
- CKD knowledge measured by the Kidney Knowledge Survey (KiKS)(Baseline up to 12 months)
- Medication Adherence Self-Efficacy Scale-Revised (MASES-R)(Baseline up to 12 months)
- Morisky Medication Adherence Scale (MMAS - 8)(Baseline up to 12 months)
- Visit Time with provider(Enrollment visit (baseline))
- Total time in clinic(Enrollment visit (baseline))
- Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)(Baseline up to 12 months)
- Satisfaction with CKD care based on Communication Assessment Tool (CAT)(Baseline up to 12 months)
- Satisfaction with CKD care based on Consultation Care Measure (CCM)(Baseline up to 12 months)
- Perceptions of health coaching for the intervention group(Baseline up to 12 months)
- Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)(Baseline up to 12 months)
- Self-reported Blood Pressure-Related Behaviors Survey(Baseline up to 12 months)
- Provider Adoption based on EMR query and patient survey(Baseline)
- Provider Fidelity measured by EMR query(Baseline)
- Provider Perception of Usefulness by provider survey(After all patient follow-ups, up to one year)
- Change in serum creatinine(Baseline, 12 months)
- Change in urine protein-creatinine ratio(Baseline, 12 months)
- Change in estimated glomerular filtration rate (eGFR)(Baseline, 12 months)
- Change in EMR-recorded blood pressure between baseline and 12 months(Baseline up to 12 months)
- Change in study visit blood pressure supplemented with EMR blood pressure if missing(Baseline up to 12 months)
- Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values(Baseline up to 12 months)
研究者
Julie Wright-Nunes
Associate Professor Department of Internal Medicine
University of Michigan