CommunityRx-Kidney Health (CRx-K)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease (Stages 1-4)
• Intervention / Treatment: Behavioral: CommunityRx-Kidney Health

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 Type: Interventional
• Enrollment (Estimated): 634
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erika M Redding, PhD, MSPH
• Study Contact Backup: Name: Kristen D Witkemper, MPH; Phone Number: 910-939-1879; Email: CRx-K@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Beulaville, North Carolina, United States, 28518
      • Recruiting
      • Goshen Medical Center
      • Contact: Donna K Sanderson, RN, BSN, CLHP; Phone Number: 4045 910-298-3125; Email: dsanderson@goshenmed.com
      • Principal Investigator: Donna K Sanderson, RN, BSN, CLHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention + usual care; This arm will receive the intervention in addition to usual care.	Behavioral: CommunityRx-Kidney Health; 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.; Other Names: CRx-K
No Intervention: Usual care only; This arm will not receive the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?"	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).	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).	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.	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.	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.	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.	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.	6 months, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Medical Mistrust Index score	The Medical Mistrust Index measures mistrust in the health system. Participants respond to 7 Likert scale items assessing the extent to which they disagree or agree with a given statement (e.g., "You'd better be cautious when dealing with health care organizations"). Items are scored from '1' (strongly disagree) to '4' (strongly agree). Higher scores indicate greater levels of mistrust in the health system.	Baseline, 6 months, 12 months
Mean estimated glomerular filtration rate (eGFR) in mL/min/1.73m²	eFGR is abstracted from participant electronic medical records.	Baseline, 6 months, 12 months
Mean creatinine in µmol/L	Creatinine is abstracted from participant electronic medical records.	Baseline, 6 months, 12 months
Mean number of comorbidities	Comorbidities are abstracted from participant electronic medical records.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Johns Hopkins University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Chicago; James McFarlin Community Development, Inc.; Project Momentum, Inc.; Goshen Medical Center; Project GRACE; UniteUs
• Investigators: Principal Investigator: Gaurav J Dave, MBBS, MPH, DrPH, University of North Carolina, Chapel Hill; Principal Investigator: Abhijit V Kshirsagar, MD, MPH, University of North Carolina, Chapel Hill; Principal Investigator: Stacy Tessler Lindau, MD, MA, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Self-efficacy; Healthcare services; Chronic disease management; Rural health; Health-related social needs; Community resource referral; Kidney health; Longitudinal navigation support
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: 24-2006; 1U01DK137262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with The University of North Carolina at Chapel Hill
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No