CommunityRx-Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease (Stages 1-4)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will individually randomize eligible participants to the CRx-CKD or usual care in a 1:1 ratio stratified by the number of providers (1, 2, or 3+) at each clinic site.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Investigators are masked to participant assignments. Unmasked research staff support the navigators as needed in enrollment and follow-up procedures. Double-masking is not possible, as participants in the active condition will receive the three CommunityRx-Chronic Kidney Disease components described during the consent process.

Study Groups

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Intervention + usual care

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

Group Type EXPERIMENTAL

CommunityRx-Chronic Kidney Disease

Intervention Type BEHAVIORAL

CommunityRx-Chronic Kidney Disease (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.

Usual care only

This arm will not receive the intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CommunityRx-Chronic Kidney Disease

CommunityRx-Chronic Kidney Disease (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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CRx-CKD HealtheRx

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No