Goshen Medical Center
Beulaville, North Carolina, 28518, United States
Location status: Recruiting
Location contact
Donna K Sanderson, RN, BSN, CLHP
CONTACT
910-298-3125 ext. 4045
Donna K Sanderson, RN, BSN, CLHP
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07237295
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beulaville, North Carolina, 28518, United States
Location status: Recruiting
Donna K Sanderson, RN, BSN, CLHP
CONTACT
910-298-3125 ext. 4045
Donna K Sanderson, RN, BSN, CLHP
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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?"
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).
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).
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of North Carolina, Chapel Hill
Other
Acronym: CRx-K
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.
Published trials that share one or more normalized conditions with this study.
NCT06329622
Atrophy, Chronic Disease
Shanghai, China
View Trial DetailsNCT07107945
Chronic Disease, Chronic Kidney Disease
Birmingham, Alabama, United States
View Trial DetailsNCT05173714
Body Weight, Chronic Disease
Stanford, California, United States
View Trial DetailsNCT07153939
Arteriovenous Fistula, Arteriovenous Malformations
Dothan, Alabama, United States
View Trial Details