- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087798
Controlling Hypertension Through Education and Coaching in Kidney Disease (CHECK-D)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ying-Jen Lin
- Email: yingjen@umich.edu
Study Contact Backup
- Name: Julie Wright
- Phone Number: 734-764-5178
- Email: juwright@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- University of Michigan / Domino's Farms
-
Ann Arbor, Michigan, United States, 48108
- University of Michigan / Briarwood Family Medicine
-
Brighton, Michigan, United States, 48116
- University of Michigan / Brighton Health Center
-
Canton, Michigan, United States, 48187
- University of Michigan / Canton Health Center
-
Chelsea, Michigan, United States, 48118
- University of Michigan / Chelsea Health Center
-
Detroit, Michigan, United States, 48201
- University Health Center - GMAP/Gen Med
-
Detroit, Michigan, United States, 48201
- University Health Center - Med Peds
-
Dexter, Michigan, United States, 48130
- University of Michigan / Dexter Health Center
-
Livonia, Michigan, United States, 48152
- University of Michigan / Livonia Health Center
-
Northville, Michigan, United States, 48168
- University of Michigan / Northville Health Center
-
Ypsilanti, Michigan, United States, 48198
- University of Michigan / Ypsilanti Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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).
Other Names:
|
Experimental: 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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 months
|
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
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.
|
Enrollment visit (baseline)
|
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.
|
Enrollment visit (baseline)
|
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
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. |
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
Medication adherence from the electronic medical record (EMR)
Time Frame: Baseline up to 12 months
|
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)
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.
|
Baseline up to 12 months
|
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.
|
Baseline up to 12 months
|
Provider Adoption based on 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.
|
Baseline
|
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.
|
Baseline
|
Provider Perception of Usefulness by provider survey
Time Frame: 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.
|
Baseline up to 12 months
|
Change in serum creatinine
Time Frame: Baseline, 12 months
|
Change in Serum Creatinine between baseline and 12-months
|
Baseline, 12 months
|
Change in urine protein-creatinine ratio
Time Frame: Baseline, 12 months
|
Baseline, 12 months
|
|
Change in estimated glomerular filtration rate (eGFR)
Time Frame: Baseline, 12 months
|
Baseline, 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Wright, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hypertension
- Kidney Diseases
- Renal Insufficiency, Chronic
- Chronic Disease
Other Study ID Numbers
- HUM00136011
- R01DK115844-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
Clinical Trials on Control-EDI
-
University Hospital of PatrasCompleted
-
Mersin UniversityCompletedPediatrics | Neurally Adjusted Ventilatory Assist | Diaphragm Electrical Activity
-
Mount Sinai Hospital, CanadaUnity Health TorontoRecruitingRespiratory Distress Syndrome, Newborn | Infant, PrematureCanada
-
University of Alabama at BirminghamNot yet recruitingInfant, Premature, Diseases | Child Development | Infant Development
-
Hospices Civils de LyonCompletedHyperalimentation and ObesityFrance
-
Hospices Civils de LyonCompletedPatient-ventilator AsynchronismFrance
-
University Hospital, CaenGenzyme, a Sanofi Company; Ligue contre le cancer, FranceCompleted
-
Medical University InnsbruckUnknownEating DisordersAustria
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn