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Trial record 8 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

Controlling Hypertension Through Education and Coaching in Kidney Disease (CHECK-D)

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ClinicalTrials.gov Identifier: NCT04087798
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Julie Wright-Nunes, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Chronic Disease Chronic Kidney Disease, Stage 3 (Moderate) Chronic Kidney Disease, Stage 4 (Severe) Chronic Kidney Disease Stage 5 Behavioral: Control-EDI Behavioral: Intervention-EDI and health coaching Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Controlling Hypertension Through Education and Coaching in Kidney Disease
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.
Behavioral: Control-EDI
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 Name: Control-Encounter Decision Intervention

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.
Behavioral: Intervention-EDI and 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 a 12-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 Name: Intervention-Encounter Decision Intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Morisky Medication Adherence Scale (MMAS - 8) [ Time Frame: Baseline up to 12 months ]
    This scale is to quantify adherence to pharmacological treatments by means of 8 items. Patients will answer yes or no to these items, where a no response = 1 point and a yes response = 0 points. Levels of adherence are based on the following scores: 3-8 = low adherence; 1-2 = medium adherence; 0 = high adherence.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Change in serum creatinine [ Time Frame: Baseline, 12 months ]
    Change in Serum Creatinine between baseline and 12-months

  20. Change in urine protein-creatinine ratio [ Time Frame: Baseline, 12 months ]
  21. Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline, 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 year documented in the medical record

Exclusion Criteria:

  • Currently on dialysis permanently (i.e. are considered "end-stage renal disease" and receiving dialysis)
  • Pregnant
  • Previous kidney transplant
  • Has cognitive, language, or vision impairment(s) that would prohibit participating in education, taking surveys, or participating in coaching activities
  • Has terminal illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087798


Contacts
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Contact: Joseph Colbert 734-936-5515 jcolbert@med.umich.edu

Locations
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United States, Michigan
University of Michigan / Domino's Farms Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Pamela Rockwell, DO         
University of Michigan / Briarwood Not yet recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Ebony Parker-Featherstone, MD         
University of Michigan / Brighton Not yet recruiting
Brighton, Michigan, United States, 48116
Contact: Mark Ealovega, MD         
University of Michigan / Chelsea Not yet recruiting
Chelsea, Michigan, United States, 48118
Contact: Jill Fenske, MD         
Wayne State University / Canfield Medicine Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Victoria Davis, MHA         
Wayne State University/Canfield-Med Peds Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Victoria Davis, MHA         
University of Michigan / Dexter Not yet recruiting
Dexter, Michigan, United States, 48130
Contact: Manasi Ramakrishnan, MD         
University of Michigan/ Livonia - Farmington Not yet recruiting
Livonia, Michigan, United States, 48152
Contact: Christine Medaugh, MD         
University of Michigan / Northville Not yet recruiting
Northville, Michigan, United States, 48168
Contact: Audrey Fan, MD         
University of Michigan / Ypsilanti Not yet recruiting
Ypsilanti, Michigan, United States, 48198
Contact: Stephen Warnick, MD         
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Julie Wright, MD University of Michigan

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Responsible Party: Julie Wright-Nunes, Assistant Professor Department of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04087798     History of Changes
Other Study ID Numbers: HUM00136011
R01DK115844-01 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes