Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT07237295
Brief Summary:
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.
Detailed 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.
Study:
NCT07237295
Study Brief:
Protocol Section:
NCT07237295