Chronic Kidney DiseasesCHECK-DNCT04087798
Controlling Hypertension Through Education and Coaching in Kidney Disease
A study testing Intervention-EDI and Health coaching in people with Chronic Kidney Diseases and Chronic Disease, run by University of Michigan at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Disease, Chronic Kidney Disease, Stage 3 (Moderate)
- What is being tested?
- Intervention-EDI and Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Feb 2020to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan / Domino's Farms
Ann Arbor, Michigan, 48105
University of Michigan / Briarwood Family Medicine
Ann Arbor, Michigan, 48108
University of Michigan / Brighton Health Center
Brighton, Michigan, 48116
University of Michigan / Canton Health Center
Canton, Michigan, 48187
University of Michigan / Chelsea Health Center
Chelsea, Michigan, 48118
University Health Center - GMAP/Gen Med
Detroit, Michigan, 48201
University Health Center - Med Peds
Detroit, Michigan, 48201
University of Michigan / Dexter Health Center
Dexter, Michigan, 48130
University of Michigan / Livonia Health Center
Livonia, Michigan, 48152
University of Michigan / Northville Health Center
Northville, Michigan, 48168
University of Michigan / Ypsilanti Health Center
Ypsilanti, Michigan, 48198
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Chronic Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease Stage 5, Hypertension
- Being tested
- Control-EDI, Intervention-EDI, Health coaching
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Disease, Lymphoma, Follicular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control-EDIBehavioural
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).
Intervention-EDIBehavioural
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 estimated glomerular filtration rate (eGFR). There is also a space for their provider to type in a sentence about specific goals for the patient.
Health coachingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control: General Kidney Disease Education | Active comparator | 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. Receives: Behavioral: Control-EDI |
| Intervention: Personalized Kidney Disease Education and Health Coaching | Experimental | 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. Receives: Behavioral: Intervention-EDI; Behavioral: Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure between baseline and 12 months
Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Measured: Baseline, 12 months
Secondary outcomes (23)
Change in Diastolic Blood Pressure between baseline and 12 months
Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Measured: Baseline, 12 months
Slope of systolic BP between baseline and 12 months using all available BP values
BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measured: Baseline up to 12 months
Slope of diastolic BP between baseline and 12 months using all available BP values
BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Measured: Baseline up to 12 months
CKD knowledge measured by the Kidney Knowledge Survey (KiKS)
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.
Measured: Baseline up to 12 months
Medication Adherence Self-Efficacy Scale-Revised (MASES-R)
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.
Measured: Baseline up to 12 months
Morisky Medication Adherence Scale (MMAS - 8)
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.
Measured: Baseline up to 12 months
Visit Time with provider
Length of time provider spends with the patient. This will be compared between the intervention group and control group.
Measured: Enrollment visit (baseline)
Total time in clinic
Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.
Measured: Enrollment visit (baseline)
Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)
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.
Measured: Baseline up to 12 months
Satisfaction with CKD care based on Communication Assessment Tool (CAT)
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.
Measured: Baseline up to 12 months
Satisfaction with CKD care based on Consultation Care Measure (CCM)
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.
Measured: Baseline up to 12 months
Perceptions of health coaching for the intervention group
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.
Measured: Baseline up to 12 months
Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
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.
Measured: Baseline up to 12 months
Self-reported Blood Pressure-Related Behaviors Survey
This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.
Measured: Baseline up to 12 months
Provider Adoption based on Electronic Medical Records (EMR) query and patient survey
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.
Measured: Baseline
Provider Fidelity measured by EMR query
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.
Measured: Baseline
Provider Perception of Usefulness by provider survey
Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.
Measured: After all patient follow-ups, up to one year
Change in serum creatinine
Change in Serum Creatinine between baseline and 12-months
Measured: Baseline, 12 months
Change in urine protein-creatinine ratio
Change in urine protein-creatinine ratio between baseline and 12-months
Measured: Baseline, 12 months
Change in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) between baseline and 12-months
Measured: Baseline, 12 months
Change in EMR-recorded blood pressure between baseline and 12 months
Changes in blood pressure recorded in the EMR from baseline to 12 months will be compared between the intervention group and control group
Measured: Baseline up to 12 months
Change in study visit blood pressure supplemented with EMR blood pressure if missing
Changes in blood pressure collected during study visits from baseline to 12 months will be compared between the intervention group and control group, with EMR data used to supplement missing values
Measured: Baseline up to 12 months
Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values
Changes in blood pressure from baseline to 12 months will be analyzed using a combined dataset that includes all available study visit and EMR blood pressure values
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start4 Feb 2020
- Primary completion1 Feb 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Design
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Wright-Nunes, University of Michigan
- Investigators
- Julie Wright-Nunes, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087798
- Sponsor's protocol ID
- HUM00136011
- Other IDs
- R01DK115844-01
- Acronym
- CHECK-D
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wright Nunes JA, Resnicow K, Richardson C, Levine D, Kerr E, Saran R, Gillespie B, Bragg-Gresham J, Delacroix EL, Considine S, Fan A, Ellies T, Garcia-Guzman L, Grzyb K, Klinkman M, Rockwell P, Billi J, Martin C, Collier K, Parker-Featherstone E, Bryant N, Seitz M, Lukela J, Brinley FJ, Fagerlin A. Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. BMJ Open. 2023 Aug 1;13(8):e071318. doi: 10.1136/bmjopen-2022-071318.
PubMed 37527897
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Hypertension Through Education and Coaching in Kidney Disease
- ClinicalTrials.gov ID
- NCT04087798
- Acronym / sponsor ID
- CHECK-D / HUM00136011
- Conditions
- Chronic Kidney Diseases, Chronic Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease Stage 5, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Design
| Arm | Type | Receives |
|---|---|---|
| Control: General Kidney Disease Education | Active comparator | Behavioral: Control-EDIEligible 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: Personalized Kidney Disease Education and Health Coaching | Experimental | Behavioral: Intervention-EDI, Behavioral: Health coachingEligible 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control-EDIPatients 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). | Behavioural | Control: General Kidney Disease Education |
| Intervention-EDIPatients 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 estimated glomerular filtration rate (eGFR). There is also a space for their provider to type in a sentence about specific goals for the patient. | Behavioural | Intervention: Personalized Kidney Disease Education and Health Coaching |
| Health coachingHealth 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). | Behavioural | Intervention: Personalized Kidney Disease Education and Health Coaching |
Primary outcome
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.
23 secondary outcomes
Change in Diastolic Blood Pressure between baseline and 12 months
Time frame: Baseline, 12 months
Slope of systolic BP between baseline and 12 months using all available BP values
Time frame: 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
CKD knowledge measured by the Kidney Knowledge Survey (KiKS)
Time frame: Baseline up to 12 months
Medication Adherence Self-Efficacy Scale-Revised (MASES-R)
Time frame: Baseline up to 12 months
Morisky Medication Adherence Scale (MMAS - 8)
Time frame: Baseline up to 12 months
Visit Time with provider
Time frame: Enrollment visit (baseline)
Total time in clinic
Time frame: Enrollment visit (baseline)
Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)
Time frame: Baseline up to 12 months
Satisfaction with CKD care based on Communication Assessment Tool (CAT)
Time frame: Baseline up to 12 months
Satisfaction with CKD care based on Consultation Care Measure (CCM)
Time frame: Baseline up to 12 months
Perceptions of health coaching for the intervention group
Time frame: 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
Self-reported Blood Pressure-Related Behaviors Survey
Time frame: Baseline up to 12 months
Provider Adoption based on Electronic Medical Records (EMR) query and patient survey
Time frame: Baseline
Provider Fidelity measured by EMR query
Time frame: Baseline
Provider Perception of Usefulness by provider survey
Time frame: After all patient follow-ups, up to one year
Change in serum creatinine
Time frame: Baseline, 12 months
Change in urine protein-creatinine ratio
Time frame: Baseline, 12 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline, 12 months
Change in EMR-recorded blood pressure between baseline and 12 months
Time frame: Baseline up to 12 months
Change in study visit blood pressure supplemented with EMR blood pressure if missing
Time frame: Baseline up to 12 months
Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 37527897Wright Nunes JA, Resnicow K, Richardson C, Levine D, Kerr E, Saran R, Gillespie B, Bragg-Gresham J, Delacroix EL, Considine S, Fan A, Ellies T, Garcia-Guzman L, Grzyb K, Klinkman M, Rockwell P, Billi J, Martin C, Collier K, Parker-Featherstone E, Bryant N, Seitz M, Lukela J, Brinley FJ, Fagerlin A. Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial. BMJ Open. 2023 Aug 1;13(8):e071318. doi: 10.1136/bmjopen-2022-071318.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Wright-Nunes, MD principal investigator
University of Michigan
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-EDI and Health coaching in people with Chronic Kidney Diseases and Chronic Disease, run by University of Michigan at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure between baseline and 12 months (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.