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NCT Number: NCT07237295

CommunityRx-Kidney Health

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goshen Medical Center

Beulaville, North Carolina, 28518, United States

Location status: Recruiting

Location contact

Donna K Sanderson, RN, BSN, CLHP

CONTACT

[email protected]

910-298-3125 ext. 4045

Donna K Sanderson, RN, BSN, CLHP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CRx-K

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ambulatory healthcare utilization

    Time frame: 12 months

    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?"

  2. Self-efficacy for finding social and self-care resources

    Time frame: 6 months, 12 months

    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).

  3. Attitudes about social and self-care resources

    Time frame: 6 months, 12 months

    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).

  4. Knowledge of social and self-care resources

    Time frame: 6 months, 12 months

    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.

  5. Use of social and self-care resources

    Time frame: 6 months, 12 months

    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. Unmet social and self-care needs

    Time frame: 6 months, 12 months

    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.

  7. Sharing of information about social and self-care resources

    Time frame: 6 months, 12 months

    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.

  8. Health-related quality of life

    Time frame: 6 months, 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erika M Redding, PhD, MSPH

CONTACT

Kristen D Witkemper, MPH

CONTACT

[email protected]

910-939-1879

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Acronym: CRx-K

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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