Chronic Kidney Disease (Stages 1-4)CRx-KNCT07237295
CommunityRx-Kidney Health
A study testing CommunityRx-Kidney Health in people with Chronic Kidney Disease (Stages 1-4), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
In the United States, the burden of chronic kidney disease (CKD) rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Kidney Health (CRx-K); this health information technology intervention integrates medical, social, and self-care resources to improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 1-4)
- What is being tested?
- CommunityRx-Kidney Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic kidney disease defined as ≥1 ICD-10 CKD codes (excluding end-stage kidney disease) or CKD biomarkers (estimated glomerular filtration rate ≤ 60 ml/min, albuminuria ≥30 mg/24h)
- At least one clinic visit at Goshen Medical Center in 12 months before enrollment
Who cannot join
- Limited life expectancy (e.g., advanced cancer, end-stage liver disease, hospice)
- Active cancer treatment
- Living in a skilled nursing facility
- Dementia/other significant cognitive impairment/inability to participate in the informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Goshen Medical Center
Beulaville, North Carolina, 28518
About this study
In the United States, the burden of chronic kidney disease (CKD) rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Kidney Health (CRx-K); this health information technology intervention integrates medical, social, and self-care resources to improve CKD management in rural eastern North Carolina. Through a partnership among local primary care centers, community organizations, and researchers, CRx-K will strengthen rural care networks, improve CKD management, and enhance the well-being of rural communities.
Read the detailed description
Approximately one in seven adults in the United States lives with chronic kidney disease (CKD). CKD typically worsens with time and, in its final stage, can result in kidney failure. Contextual factors in rural, eastern North Carolina communities impede optimal management of CKD multimorbidity. In these communities, geographical barriers to medical care, dwindling resources, and underdeveloped health infrastructure have worsened CKD outcomes. CommunityRx-Kidney Health (CRx-K) is an evidence-based, low-intensity, health information technology-driven intervention designed to support CKD management in rural eastern North Carolina. CRx-K integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-K comprises three components: brief education on integrated CKD needs, a personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for CKD patients in our trial. Our multidisciplinary, community-engaged research team will test the effects of CRx-K through three related aims.
This pragmatic individual-randomized, two-arm, single-blind trial in 35 rural primary care clinics in 16 rural eastern North Carolina counties (n=634 adults with CKD) assesses the effect of CRx-K on acute healthcare utilization (primary outcome), self-efficacy for finding resources, knowledge and sharing of integrated care resources, resource use, number of unmet needs over time, ambulatory care utilization, and health-related quality of life. The researchers hypothesize that 12-month acute healthcare utilization will differ between participants receiving CRx-K and those receiving usual care.
- Conditions
- Chronic Kidney Disease (Stages 1-4)
- Being tested
- CommunityRx-Kidney Health
- Keywords
- Chronic disease management, Community resource referral, Health-related social needs, Healthcare services, Kidney health, Longitudinal navigation support, Rural health, Self-efficacy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunityRx-Kidney HealthBehavioural
Also called CRx-K
CommunityRx-Kidney Health (CRx-K) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-K integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-K comprises three components: brief education on integrated chronic kidney disease needs, a personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention + usual care | Experimental | This arm will receive the intervention in addition to usual care. Receives: Behavioral: CommunityRx-Kidney Health |
| Usual care only | No intervention | This arm will not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute healthcare utilization
Acute healthcare utilization is measured as the sum of self-reported 911 calls, ambulance visits, emergency room visits, urgent care visits, and hospital admissions across the 12-month follow-up period.
Measured: 12 months
Secondary outcomes (8)
Ambulatory healthcare utilization
Number of ambulatory (physician office) visits across the 12-month follow-up period is self-reported based on responses to an item originally used in DIAMOND RCT: "How many times have you seen a physician for an office visit?"
Measured: 12 months
Self-efficacy for finding social and self-care resources
Self-efficacy for finding social and self-care resources is measured using an item developed from Bandura's self-efficacy theory and used in prior CommunityRx trials: "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 4-point Likert scale ranging from '1' (not at all confident) to '4' (completely confident).
Measured: 6 months, 12 months
Attitudes about social and self-care resources
Attitude about social and self-care resources are measured using a self-report Likert item adapted and tested in prior CommunityRx studies: "Your community has the resources you need to manage your health." Response options range from '1' (strongly agree) to '5' (strongly disagree).
Measured: 6 months, 12 months
Knowledge of social and self-care resources
Knowledge of social and self-care resources is measured using a self-reported item adapted and tested in prior CommunityRx studies and repeated for 12 resource types: "Do you know of places in your community that offer [resource type]?" The research team will report the sum of resource types that participants endorse knowledge of.
Measured: 6 months, 12 months
Use of social and self-care resources
Use of social and self-care resources (for which a participant reports knowledge) is measured using a self-report item adapted and tested in prior CommunityRx studies and repeated for 12 resource types: "Have you received services from places like this for you or your household in the past 3 months?" The research team will report the total number of resource types that participants endorse using.
Measured: 6 months, 12 months
Unmet social and self-care needs
Unmet social and self-care needs are measured using self-report items adapted and tested in prior CommunityRx studies and repeated for 12 resource types. Participants who report not having used a resource type in the past 3 months respond to: "Is this a service that you or your household needs?" Participants who report having used a resource type in the past 3 months respond to: "Do these places meet your [resource type] needs?" The research team will report the total number of resource types that participants endorse needing.
Measured: 6 months, 12 months
Sharing of information about social and self-care resources
Sharing of social and self-care resources (for which a participant reports knowledge) is measured using a self-report item adapted and tested in prior CommunityRx studies and repeated for 12 resource types: "Did you tell anyone about places like this in the past 3 months?" The research team will report the sum of resource types that participants endorse sharing.
Measured: 6 months, 12 months
Health-related quality of life
The 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 assesses general health-related quality of life and is self-reported. Response options are presented as nine 5-point and one 11-point Likert scales. Higher raw sum scores indicate greater health-related quality-of-life.
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start13 Apr 2026
- Primary completion8 Sep 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 1-4)Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research team will use REDCap's randomization module to individually randomize eligible participants to the CRx-K or usual care in a 1:1 ratio stratified by the number of providers (1, 2, or 3+) at each clinic site.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Goshen Medical Center, James McFarlin Community Development, Inc., Johns Hopkins University, Project GRACE, Project Momentum, Inc., UniteUs, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Gaurav J Dave, MBBS, MPH, DrPH, Principal investigator, University of North Carolina, Chapel HillAbhijit V Kshirsagar, MD, MPH, Principal investigator, University of North Carolina, Chapel HillStacy Tessler Lindau, MD, MA, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237295
- Sponsor's protocol ID
- 24-2006
- Other IDs
- 1U01DK137262
- Acronym
- CRx-K
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx-Kidney Health
- ClinicalTrials.gov ID
- NCT07237295
- Acronym / sponsor ID
- CRx-K / 24-2006
- Conditions
- Chronic Kidney Disease (Stages 1-4)
- Keywords
- Chronic disease management, Community resource referral, Health-related social needs, Healthcare services, Kidney health, Longitudinal navigation support, Rural health, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Goshen Medical Center, James McFarlin Community Development, Inc., Johns Hopkins University, Project GRACE, Project Momentum, Inc., UniteUs, University of Chicago
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
In the United States, the burden of chronic kidney disease (CKD) rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Kidney Health (CRx-K); this health information technology intervention integrates medical, social, and self-care resources to improve CKD management in rural eastern North Carolina. Through a partnership among local primary care centers, community organizations, and researchers, CRx-K will strengthen rural care networks, improve CKD management, and enhance the well-being of rural communities.
Detailed description
Approximately one in seven adults in the United States lives with chronic kidney disease (CKD). CKD typically worsens with time and, in its final stage, can result in kidney failure. Contextual factors in rural, eastern North Carolina communities impede optimal management of CKD multimorbidity. In these communities, geographical barriers to medical care, dwindling resources, and underdeveloped health infrastructure have worsened CKD outcomes. CommunityRx-Kidney Health (CRx-K) is an evidence-based, low-intensity, health information technology-driven intervention designed to support CKD management in rural eastern North Carolina. CRx-K integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-K comprises three components: brief education on integrated CKD needs, a personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for CKD patients in our trial. Our multidisciplinary, community-engaged research team will test the effects of CRx-K through three related aims.
This pragmatic individual-randomized, two-arm, single-blind trial in 35 rural primary care clinics in 16 rural eastern North Carolina counties (n=634 adults with CKD) assesses the effect of CRx-K on acute healthcare utilization (primary outcome), self-efficacy for finding resources, knowledge and sharing of integrated care resources, resource use, number of unmet needs over time, ambulatory care utilization, and health-related quality of life. The researchers hypothesize that 12-month acute healthcare utilization will differ between participants receiving CRx-K and those receiving usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The research team will use REDCap's randomization module to individually randomize eligible participants to the CRx-K or usual care in a 1:1 ratio stratified by the number of providers (1, 2, or 3+) at each clinic site.
| Arm | Type | Receives |
|---|---|---|
| Intervention + usual care | Experimental | Behavioral: CommunityRx-Kidney HealthThis arm will receive the intervention in addition to usual care. |
| Usual care only | No intervention | –This arm will not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic kidney disease defined as ≥1 ICD-10 CKD codes (excluding end-stage kidney disease) or CKD biomarkers (estimated glomerular filtration rate ≤ 60 ml/min, albuminuria ≥30 mg/24h)
- At least one clinic visit at Goshen Medical Center in 12 months before enrollment
Key exclusion criteria (4 listed)
- Limited life expectancy (e.g., advanced cancer, end-stage liver disease, hospice)
- Active cancer treatment
- Living in a skilled nursing facility
- Dementia/other significant cognitive impairment/inability to participate in the informed consent process
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 |
|---|---|---|
| CommunityRx-Kidney HealthAlso: CRx-KCommunityRx-Kidney Health (CRx-K) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-K integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-K comprises three components: brief education on integrated chronic kidney disease needs, a personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients. | Behavioural | Intervention + usual care |
Primary outcome
Acute healthcare utilization
Time frame: 12 months
Acute healthcare utilization is measured as the sum of self-reported 911 calls, ambulance visits, emergency room visits, urgent care visits, and hospital admissions across the 12-month follow-up period.
8 secondary outcomes
Ambulatory healthcare utilization
Time frame: 12 months
Self-efficacy for finding social and self-care resources
Time frame: 6 months, 12 months
Attitudes about social and self-care resources
Time frame: 6 months, 12 months
Knowledge of social and self-care resources
Time frame: 6 months, 12 months
Use of social and self-care resources
Time frame: 6 months, 12 months
Unmet social and self-care needs
Time frame: 6 months, 12 months
Sharing of information about social and self-care resources
Time frame: 6 months, 12 months
Health-related quality of life
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
Related trials for Chronic Kidney Disease (Stages 1-4)
Not yet recruitingObservational study
Diet and Progression of CKD in Patients With Type 2 Diabetes Mellitus
CKD Stage 1-4, Diet Pattern Analysis
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.
Gaurav J Dave, MBBS, MPH, DrPH principal investigator
University of North Carolina, Chapel Hill
Abhijit V Kshirsagar, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Stacy Tessler Lindau, MD, MA principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CommunityRx-Kidney Health in people with Chronic Kidney Disease (Stages 1-4), run by University of North Carolina, Chapel Hill at 1 site 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute healthcare utilization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.