ClinicalTrials.Veeva

Menu

CommunityRx-Chronic Kidney Disease (CRx-CKD)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Not yet enrolling

Conditions

Chronic Kidney Disease (Stages 1-4)

Treatments

Behavioral: CommunityRx-Chronic Kidney Disease

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT07237295
24-2006
1U01DK137262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In the United States, the burden of chronic kidney disease rests disproportionately on rural communities. This study evaluates the implementation and effectiveness of CommunityRx-Chronic Kidney Disease (CRx-CKD); 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-CKD will strengthen rural care networks, improve CKD management, and enhance the well-being of rural communities.

Full description

Approximately one in seven adults in the United States lives with chronic kidney disease. Chronic kidney disease 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 chronic kidney disease multimorbidity. In these communities, geographical barriers to medical care, dwindling resources, and underdeveloped health infrastructure have worsened chronic kidney disease outcomes. CommunityRx-CKD (CRx-CKD) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-CKD 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-CKD comprises three components: brief education on integrated chronic kidney disease needs, a chronic kidney disease care plan that includes integrated care referrals, and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients in our trial. Our multidisciplinary, community-engaged research team will test the effects of CRx-CKD through three related aims.

This pragmatic individual-randomized, two-arm, single-blind trial in 25 rural primary care clinics in 12 rural eastern North Carolina counties (n=634 adults with CKD) assesses the effect of CRx-CKD 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-CKD and those receiving usual care.

Enrollment

634 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

634 participants in 2 patient groups

Intervention + usual care
Experimental group
Description:
This arm will receive the intervention in addition to usual care.
Treatment:
Behavioral: CommunityRx-Chronic Kidney Disease
Usual care only
No Intervention group
Description:
This arm will not receive the intervention.

Trial contacts and locations

1

Loading...

Central trial contact

Kristen D Witkemper, MPH; Erika M Redding, PhD, MSPH

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems