Recruiting

KHC Intervention

Sponsor:

Emory University

Code:

NCT06693661

Conditions

Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Kidney Health Coaching

Usual Care

Study Details

Brief summary:

Through the use of community-engaged processes, this project seeks to develop and implement clinical decision support (CDS) and a kidney health coaching (KHC) intervention. The CDS seeks to streamline workflows to effectively screen, identify, and link to care for those patients with advanced chronic kidney disease (CKD).

The overall project goals are to 1.) Design and conduct community-engaged clinical trials to test new interventions that dismantle the systemic factors that contribute to kidney health disparities. 2.) Foster research collaborations between investigators, people living with kidney disease, community-based organizations, and other key stakeholders.

Researchers aim to assess whether the KHC intervention is effective at delaying the transition to kidney replacement therapy (KRT) and central venous catheter use or death.

Conditions

Kidney Diseases

Study ID

NCT06693661

Start date

Mar 10, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Identifies as African American or Black
  • Two estimated glomerular filtration rates (eGFRs) < 29 separated by at least 90 days but within the past 2 years, or a Kidney Failure Risk Equation (KFRE) score of 10% or greater likelihood of kidney failure within the next 2 years
  • Had an encounter at Emory Healthcare through an ambulatory visit or inpatient stay (i.e., ER or hospital visit within the previous 2 months
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Currently on dialysis
  • currently receiving hospice care or other types of conservative management for terminal illness
  • Currently on waitlist, or referred for/or completed a transplant evaluation visit within the past 2 years
  • Kidney or another solid organ transplant
  • Active cancer treatment
  • Non-English speaking
  • Participating in another treatment or intervention study at the time of enrollment
  • Currently pregnant or planning to become pregnant at the time of recruitment

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Intervention: Kidney Health Coaching

Participants will receive patient-centered health coaching delivered by three full-time kidney health coaches for six months.

other: Control: Usual Care

Participants will receive the usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)

Interventions

Kidney Health Coaching

The intervention entails support from a KHC that includes:

  • An initial rapport-building call
  • Ongoing telephone support at least twice a month for six months
  • Meeting the patient at all in-person clinic appointments
  • Documenting interactions in the EMR using a customized platform

Telephone support begins with a social determinants of health (SDoH) screening tool to identify barriers and facilitators to CKD self-management and appointment adherence. This tool provides access to local resources based on the patient's ZIP code. Subsequent calls will follow up on resource usage, review CKD educational materials and treatment options, complete the Decision Aid for Renal Therapy tool, and facilitate communication through the patient portal. Each call will start with specific goals (e.g., review National Kidney Foundation CKD materials) and conclude with goals for the next session.

Usual Care

ER Discharge (d/c): Participants may receive consultations and support from Care Management in the ER, such as transportation or medication assistance. Follow-up by a social worker varies post-discharge.

Hospital d/c: All hospitalized patients are assessed by the care management team to identify psychosocial needs and begin discharge planning, which may include follow-up appointments and resources. High-risk patients receive additional follow-up from a care transitions coordinator for 30 days post-discharge.

Primary Care: Patients in primary care clinics have access to various support services. Those recently hospitalized or identified as high-risk receive care coordination from social workers. Internal referrals are managed by referral coordinators, while external referrals come from clinic staff. Discharge information is provided after visits.

Nephrology: There are no coordinated support services for chronic kidney disease (CKD) patients receiving nephrology care.

Primary outcome measure

  • Time-to-Kidney Replacement Therapy w/Central Venous Catheter [ Time Frame: Throughout study participation up to 12 months ]
  • Time-to-death [ Time Frame: Throughout study participation up to 12 months ]

Central Contacts and Locations

Central contacts

Kimberly R Jacob Arriola, PhD, MPH

404-727-2600kjacoba@emory.edu

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Emory Healthcare System

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • African American
  • Health Disparities
  • Chronic Care Model (CCM)
  • Kidney Health Coach (KHC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-04.