CommunityRx-Kidney Health

NCT07237295 | Recruiting

• 2 other identifiers: 24-20061U01DK137262
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ambulatory healthcare utilization

  12 months

• Self-efficacy for finding social and self-care resources

  6 months, 12 months

• Attitudes about social and self-care resources

  6 months, 12 months

• Knowledge of social and self-care resources

  6 months, 12 months

• Use of social and self-care resources

  6 months, 12 months

Study Arms (2)

Intervention + usual care

EXPERIMENTAL

This arm will receive the intervention in addition to usual care.

Behavioral: CommunityRx-Kidney Health

Usual care only

NO INTERVENTION

This arm will not receive the intervention.

Interventions

CommunityRx-Kidney Health BEHAVIORAL

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.

Also known as: CRx-K

Intervention + usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James McFarlin Community Development, Inc.: collaborator
• Johns Hopkins University: collaborator
• Project GRACE: collaborator
• Project Momentum, Inc.: collaborator
• University of Chicago: collaborator
• Goshen Medical Center: collaborator
• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• UniteUs: collaborator

Study Sites (1)

Goshen Medical Center

Beulaville, North Carolina, 28518, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen D Witkemper, MPH

CONTACT

910-939-1879; CRx-K@med.unc.edu

Erika M Redding, PhD, MSPH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators are masked to participant assignments. Unmasked research staff support enrollment, randomization, and data collection; unmasked navigators deliver the intervention to participants randomized to the active arm. Participant masking is not possible, as participants in the active condition will receive the three CRx-K components described during the consent process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Beginning 9 and continuing for 36 months following publication
• 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

Locations

US (1)