CommunityRx for Chronic Kidney Disease

(CRx-CKD Trial)

Overseen By Erika M Redding, PhD, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Advanced cancer, End-stage liver disease, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve chronic kidney disease (CKD) management in rural areas, specifically in eastern North Carolina. It employs a program called CommunityRx-Chronic Kidney Disease (CRx-CKD) to connect patients with medical, social, and self-care resources. Participants will receive either the new intervention alongside their usual care or just their usual care. The trial seeks individuals diagnosed with CKD who have visited the Goshen Medical Center at least once in the past year. As an unphased trial, it offers participants the chance to contribute to innovative CKD management approaches and potentially benefit from enhanced care resources.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this health information technology intervention is safe for chronic kidney disease management?

Research shows that CommunityRx, a system providing social care in healthcare settings, is generally safe. Previous studies have not identified any major negative side effects with CommunityRx, indicating it is well-tolerated. Since CommunityRx-Chronic Kidney Disease (CRx-CKD) is a similar tool, it is likely safe as well. However, specific data on negative effects for CRx-CKD itself is not available. It is important to understand that CRx-CKD is not a medication or procedure. Instead, it connects patients with medical and social resources to better manage chronic kidney disease. This type of support generally poses a low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CommunityRx for Chronic Kidney Disease because it introduces a novel approach to patient care, integrating a community-based resource referral system alongside usual medical care. Unlike standard treatments that primarily focus on medication and dietary changes, this innovative method aims to connect patients with local health and social services, potentially addressing lifestyle and socioeconomic factors that influence kidney health. By providing personalized resources and support, CommunityRx could enhance patient engagement and self-management, potentially leading to improved health outcomes and quality of life for those living with chronic kidney disease.

What evidence suggests that CommunityRx-Chronic Kidney Disease is effective for managing chronic kidney disease?

Research shows that CommunityRx-Chronic Kidney Disease (CRx-CKD) can help manage chronic kidney disease (CKD) by linking patients to local resources and support. CommunityRx uses personal information to provide customized recommendations for community services that assist with health and caregiving needs. In this trial, one group will receive the CRx-CKD intervention in addition to usual care, while another group will receive usual care only. Studies have found that similar programs have reduced hospital visits and lowered costs for people with advanced CKD. This suggests that CRx-CKD could improve CKD management by offering access to important local support, potentially leading to better health outcomes for those in rural areas. ^{1 2 6 7 8}

Who Is on the Research Team?

Gaurav J Dave, DrPH, MPH, MBBS

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals with chronic kidney disease living in rural eastern North Carolina. It aims to help them manage their condition better by providing integrated medical, social, and self-care resources.

Inclusion Criteria

At least one clinic visit at Goshen Medical Center in 12 months before enrollment

I have chronic kidney disease but not end-stage kidney disease.

Exclusion Criteria

Limited life expectancy (e.g., advanced cancer, end-stage liver disease, hospice)

Living in a skilled nursing facility

I do not have dementia or significant cognitive issues affecting my understanding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Care Plan Development

Participants receive brief education on integrated chronic kidney disease needs and a care plan that includes integrated care referrals

1 month

Longitudinal Support

Clinic navigator-led, longitudinal support for chronic kidney disease patients

12 months

Regular check-ins (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CommunityRx-Chronic Kidney Disease

Trial Overview The study tests the CommunityRx-Chronic Kidney Disease (CRx-CKD) intervention. This health information technology tool connects patients with local care networks and resources to improve management of chronic kidney disease.

How Is the Trial Designed?

Group I: Intervention + usual care Experimental Treatment 1 Intervention

This arm will receive the intervention in addition to usual care.

Group II: Usual care only Active Control 1 Intervention

This arm will not receive the intervention.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

James McFarlin Community Development, Inc.

Collaborator

Trials

2

Recruited

350+

Unite Us

Collaborator

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Project GRACE

Collaborator

Project Momentum, Inc.

Industry Sponsor

Trials

2

Recruited

350+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Goshen Medical Center

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07237295

CommunityRx-Chronic Kidney Disease (CRx-CKD) This study evaluates the implementation and effectiveness of CommunityRx-Chronic Kidney Disease (CRx-CKD); this health information technology ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10624358/

CommunityRx, a social care assistance intervention for family ... CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two ...

3. voices.uchicago.edu voices.uchicago.edu/lindaulab/communityrx/

Community Rx Revamp | The Lindau Lab - UChicago Voices CommunityRx is an evidence and theory-based, low-intensity, highly scalable supportive care intervention designed with community input over time.

4. kidney.org kidney.org/sites/default/files/ajmc-11-2019-vassalotti-11-4-19.pdf

CKD Quality Improvement Intervention With PCMH ... For advanced CKD, decreased hospitalization and a reduction in several important costs were observed. These preliminary results support the stratification of ...

5. acpjournals.org acpjournals.org/doi/abs/10.7326/M22-1543

Annals of Internal Medicine Conclusion: DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART ...

6. reporter.nih.gov reporter.nih.gov/search/iShc9u0-CEC_d6HjcuvhLw/project-details/8231935

Health IT Enhanced for CKD in Safety-Net Primary Care DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) is common in U.S. adults and is associated with excess mortality and morbidity.

7. researchgate.net researchgate.net/publication/374898685_CommunityRx_a_social_care_assistance_intervention_for_family_and_friend_caregivers_delivered_at_the_point_of_care_two_concurrent_blinded_randomized_controlled_trials

two concurrent blinded randomized controlled trials Background CommunityRx is an evidence‑based social care intervention delivered to family and friend caregivers.

8. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-024-03829-y

a scoping review and modified Delphi - BMC Nephrology This study provides an expert consensus of the top 40 medications that community pharmacists should collaboratively adjust or avoid to enhance medication ...