CommunityRx-Kidney Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CommunityRx-Kidney Health.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease (Stages 1-4). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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
Primary outcome measures
- Acute healthcare utilization [Time frame: 12 months]
Secondary outcome measures (8)
- Ambulatory healthcare utilization [Time frame: 12 months]
- Self-efficacy for finding social and self-care resources [Time frame: 6 months, 12 months]
- Attitudes about social and self-care resources [Time frame: 6 months, 12 months]
- Knowledge of social and self-care resources [Time frame: 6 months, 12 months]
- Use of social and self-care resources [Time frame: 6 months, 12 months]
- Unmet social and self-care needs [Time frame: 6 months, 12 months]
- Sharing of information about social and self-care resources [Time frame: 6 months, 12 months]
- Health-related quality of life [Time frame: 6 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Goshen Medical Center — Beulaville
Identifiers
NCT: NCT07237295 · 24-2006 · 1U01DK137262