Recruiting

CHOOSE Home Intervention

Sponsor:

Montefiore Medical Center

Code:

NCT06925776

Conditions

Kidney Replacement Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHOOSE Home Intervention

Usual Care

Study Details

Brief summary:

The goal of this clinical trial is to learn if this intervention (the CHOOSE Home intervention) is feasible and may lead to more home dialysis usage in a high-risk patient population. The main questions it aims to answer are:

  • Will there be an increase in home dialysis selection or initiation over study follow up?
  • Will there be a change in patient reported status of Health-Related Social Needs (HRSNs) and patient engagement at 1 year follow up?

Researchers will compare the intervention group that will include interdisciplinary care (IDC) and the integration of a Community Health Worker (CHW) into the chronic kidney disease (CKD) care process to the IDC only control group. The research team will assess whether the intervention led to better social care navigation, enhanced patient engagement, and increased home dialysis use.

Conditions

Kidney Replacement Therapy

Study ID

NCT06925776

Start date

Dec 12, 2025

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Advanced CKD (defined by estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73m2 or less using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)
  • English or Spanish speaking
  • Provide informed consent
  • Followed by a nephrologist at Montefiore and seen within last 12 months
  • Willing to receive interdisciplinary care (i.e., nurse practitioner facilitated CKD education and care coordination)

Exclusion Criteria:

  • Active malignancy
  • Anticipated survival is less than 1 year as determined by the patient's treating nephrologist
  • Opting to do medical management only (non- dialysis supportive care) for management of their kidney failure
  • Plan to relocate outside of New York City within the next 12 months

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: CHW facilitated social care navigation and peer support as part of IDC

Patients will receive community health worker (CHW) facilitated social care navigation and peer support around kidney replacement therapy (KRT) decision-making as part of their interdisciplinary care (IDC) for CKD, up to 1 year.

Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

other: IDC alone

Patients will receive IDC (Interdisciplinary Care) only. They will not receive CHW (Community Health Worker) facilitated peer support and social care navigation.

Participants will complete surveys, questionnaires, or interviews at baseline, 6 months, and 12 months.

Interventions

CHOOSE Home Intervention

Integration of a CHW (Community Health Worker) in the CKD (Chronic Kidney Disease) care process to augment patient engagement and address HRSNs (Health-Related Social Needs) within the context of an IDC (Interdisciplinary Care) CKD clinic. The multifaceted components of the intervention are tailored to address key care delivery and social barriers to home dialysis utilization before implementation.

Usual Care

This is the usual interdisciplinary care that patients would typically receive for their chronic kidney disease. A key missing factor here is the lack of a community health worker. Patients in this group will be screened for health-related social needs and receive general information on ways to access social services from a study coordinator. Patients will not receive facilitated peer support and social care navigation from the Community Health Worker.

Primary outcome measure

  • Selection or Initiation of Home Dialysis [ Time Frame: 1 year study follow up period ]

Central Contacts and Locations

Central contacts

Yaxkyn A Mejia, BS

718-430-2064yaxkyn.mejia@einsteinmed.edu

Locations

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Yaxkyn A Mejia, BA

718-430-2064yaxkyn.mejia@einsteinmed.edu

Principal Investigator:

Tanya S Johns, MD, MHS

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Community Health Worker
  • Interdisciplinary Care
  • Kidney Replacement Therapy
  • home dialysis
  • Health-Related Social Needs
  • patent engagement
  • Hemodialysis
  • home hemodialysis
  • peritoneal dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-15.