Chronic Kidney Disease (Stages 1-4)
Conditions
Keywords
Chronic disease management, Community resource referral, Health-related social needs, Healthcare services, Kidney health, Longitudinal navigation support, Rural health, Self-efficacy
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.
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
BEHAVIORALCommunityRx-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 personalized community resource referral list (HealtheRx), and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients.
Sponsors
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Goshen Medical Center
James McFarlin Community Development, Inc.
Johns Hopkins University
Project GRACE
Project Momentum, Inc.
UniteUs
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute healthcare utilization | 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
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory healthcare utilization | 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?" |
| Self-efficacy for finding social and self-care resources | 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). |
| Attitudes about social and self-care resources | 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). |
| Knowledge of social and self-care resources | 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. |
| Use of social and self-care resources | 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. |
| Unmet social and self-care needs | 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. |
| Sharing of information about social and self-care resources | 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. |
| Health-related quality of life | 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. |
Countries
United States
Contacts
CONTACTKristen D Witkemper, MPH
CONTACTErika M Redding, PhD, MSPH
PRINCIPAL_INVESTIGATORGaurav J Dave, MBBS, MPH, DrPH
University of North Carolina, Chapel Hill
PRINCIPAL_INVESTIGATORAbhijit V Kshirsagar, MD, MPH
University of North Carolina, Chapel Hill
PRINCIPAL_INVESTIGATORStacy Tessler Lindau, MD, MA
University of Chicago
Outcome results
None listed