Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT06693661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaborative Learning to Achieve Refined Interventions for Emory: Kidney Disease
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Improving Access to Nephrology Treatment and Care Among Patients at Greatest Risk for Kidney Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLARIFy-KD
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.
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.
Detailed Description:
This study has two Aims. In Aim 1, the research team will develop and implement multi-level, multi-component interventions across primary care and acute care access points, nephrology, and dialysis care using the Chronic Care Model as an organizing framework.
Aim 1: Implement multi-level, multi-component interventions across primary care and acute care access points, nephrology, and dialysis care using the Chronic Care Model as an organizing framework. The research team will deliver patient-centered kidney health coaching, with full-time kidney health coaches (KHC). They must have lived experience with chronic kidney disease (CKD) and will be selected for certain personality characteristics. The KHCs will undergo training to deliver patient support that aligns with 4 constructs of the Chronic Care Model: Clinical information systems, Patient self-management, and treatment decision-making support, Delivery system redesign, and Community resources. Participants enrolled in the intervention will receive 6-months of kidney health coaching. Those eligible for participation will be invited to participate and undergo the informed consent process via telephone. Next, study staff will administer the baseline assessment via telephone interview for those who consent.
Aim 2: Using a 2-group randomized controlled trial, determine the effectiveness of the interventions on primary outcomes analyzed at the level of patients (i.e., referral to nephrology and preemptive transplant, uptake of home hemodialysis).
Aim 1: Implement multi-level, multi-component interventions across primary care and acute care access points, nephrology, and dialysis care using the Chronic Care Model as an organizing framework. The research team will deliver patient-centered kidney health coaching, with full-time kidney health coaches (KHC). They must have lived experience with chronic kidney disease (CKD) and will be selected for certain personality characteristics. The KHCs will undergo training to deliver patient support that aligns with 4 constructs of the Chronic Care Model: Clinical information systems, Patient self-management, and treatment decision-making support, Delivery system redesign, and Community resources. Participants enrolled in the intervention will receive 6-months of kidney health coaching. Those eligible for participation will be invited to participate and undergo the informed consent process via telephone. Next, study staff will administer the baseline assessment via telephone interview for those who consent.
Aim 2: Using a 2-group randomized controlled trial, determine the effectiveness of the interventions on primary outcomes analyzed at the level of patients (i.e., referral to nephrology and preemptive transplant, uptake of home hemodialysis).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01DK137269 | NIH | None | https://reporter.nih.gov/quic… | View |
| 2025P008750 | OTHER | Emory IRB | View |