Kidney Replacement TherapyCHOOSE HomeNCT06925776
Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization
A study testing CHOOSE Home Intervention in people with Kidney Replacement Therapy, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Replacement Therapy
- What is being tested?
- CHOOSE Home Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Yaxkyn A Mejia, BA, 718-430-2064, yaxkyn.mejia@einsteinmed.edu
Tanya S Johns, MD, MHS
About this study
Official title: Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization- the CHOOSE Home Trial
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.
Read the detailed description
The overarching aims of the study are to 1) utilize a community- engaged approach with input from diverse community partners to refine the CHOOSE Home Trial; and 2) evaluate the feasibility, acceptability, and possible effect of the CHOOSE Home Intervention. Feasibility and acceptability will be evaluated using complementary quantitative and qualitative measures and organized into the dimensions of the RE-AIM framework. The investigator team hypothesizes that the CHOOSE Home intervention may lead to increased home dialysis utilization by more effectively addressing health-related social needs and fostering greater patient engagement. This proposal brings together experts in CKD care, SDOH, health equity, implementation and community-engaged research. The results will be used to inform further studies in CKD care delivery to reduce health inequities in home dialysis use and improve the quality of life for patients with CKD.
- Conditions
- Kidney Replacement Therapy
- Being tested
- CHOOSE Home Intervention, Usual Care
- Keywords
- Community Health Worker, Interdisciplinary Care, Kidney Replacement Therapy, home dialysis, Health-Related Social Needs, patent engagement, Hemodialysis, home hemodialysis, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOOSE Home InterventionOther
Also called CHW Intervention, CHW + IDC Intervention, IDC + CHW
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 CareOther
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| CHW facilitated social care navigation and peer support as part of IDC | Other | 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. Receives: Other: CHOOSE Home Intervention |
| IDC alone | Other | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selection or Initiation of Home Dialysis
The percentage of patients who select or initiate home dialysis in each study arm will be summarized by study arm. To account for patients who may not progress to end-stage kidney disease (ESKD) within one year, this percentage will be defined as the sum of non-ESKD patients choosing home dialysis and ESKD patients who start home dialysis, divided by the total patients in each group.
Measured: 1 year study follow up period
Secondary outcomes (2)
Change in Patient Activation Measure Scores
Change in Patient Activation Measure (Patient Engagement) will be assessed by assessment of the Patient Activation Measure (PAM) survey at baseline, 6 months, and 1 year.
The PAM is a 13-item survey designed to assess a patient's knowledge, beliefs, confidence, and skills about managing one's healthcare. Each item is scored on a 4-point Likert scale ranging from 1 ("Strongly disagree") to 4 ("Strongly Agree"). Raw scores are transformed to a scale with a theoretical range of 0-100, based on calibration tables, with higher PAM scores indicating higher levels of patient activation.
For purposes of this study, change from baseline to 6 months and 1 year will be assessed, and positive percentage scores will indicate increased patient activation.
The percentage of patients in each arm with a 6-point PAM increase over a period of 6-12 months will be summarized by study arm.
Measured: From baseline to 6 months and baseline to 1 year
Change in patient-reported status of Health-related social needs (HRSNs)
HRSNs will be assessed by the by administration of the Accountable Health Communities Health-Related Social Needs (AHC-HRSN) survey at baseline and 1 year.
The AHC-HRSN is a 26-item screening tool designed to help providers identify patients' needs. This study will focus on five core domains captured in the first 10-items of the screening tool. The five core domains are housing instability, food insecurity, transportation problems, interpersonal safety, and utility help. If a patient answers positively to any domain(s) and desires assistance, they are considered to have that corresponding health-related social need.
Change in HRSN status (i.e., resolved/progress made or no progress) from baseline to 6 months and 1 year will be categorized and summarized by study arm.
Measured: From baseline to 6 months and baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start12 Dec 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Kidney Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, pragmatic, randomized, parallel two-arm single site trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York University
- Responsible party
- Sponsor
- Investigators
- Tanya S Johns, MD, MHS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925776
- Sponsor's protocol ID
- 2025-16868
- Other IDs
- 1R01DK140574-01, 2025
- Acronym
- CHOOSE Home
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with NIH guidelines, the study team will share data with qualified investigators whose research protocols have been approved by their institutions' Institutional Review Boards. The final dataset will include qualitative and quantitative data including anonymized transcripts, socio-demographics, medical history, social history, and clinical outcomes data. The dataset will be stripped of all personal identifiers according to HIPAA and the Common Rule. The investigator team plans to submit anonymized data to a generalist repository, Vivli, that is participating in the NIH Generalist Repository Ecosystem Initiative (GREI) so that it can be made available to other investigators under an NIH-approved data-sharing agreement that ensures that: (1) data is used only for research purposes and does not identify individual participants; (2) data is handled in a secure and confidential way; and (3) data is destroyed or returned after analyses are completed.
Publications
United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022.
Francois K, Bargman JM. Evaluating the benefits of home-based peritoneal dialysis. Int J Nephrol Renovasc Dis. 2014 Dec 4;7:447-55. doi: 10.2147/IJNRD.S50527. eCollection 2014.
PubMed 25506238Johns TS, Prudhvi K, Motechin RA, Sedaliu K, Estrella MM, Stark A, Bauer C, Golestaneh L, Boulware LE, Melamed ML. Interdisciplinary Care and Preparedness for Kidney Failure Management in a High-Risk Population. Kidney Med. 2022 Mar 17;4(5):100450. doi: 10.1016/j.xkme.2022.100450. eCollection 2022 May.
PubMed 35479194Johns TS, Yee J, Smith-Jules T, Campbell RC, Bauer C. Interdisciplinary care clinics in chronic kidney disease. BMC Nephrol. 2015 Oct 12;16:161. doi: 10.1186/s12882-015-0158-6.
PubMed 26458811Cho EJ, Park HC, Yoon HB, Ju KD, Kim H, Oh YK, Yang J, Hwang YH, Ahn C, Oh KH. Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. Nephrology (Carlton). 2012 Jul;17(5):472-9. doi: 10.1111/j.1440-1797.2012.01598.x.
PubMed 22435951Hsu HT, Chiang YC, Lai YH, Lin LY, Hsieh HF, Chen JL. Effectiveness of Multidisciplinary Care for Chronic Kidney Disease: A Systematic Review. Worldviews Evid Based Nurs. 2021 Feb;18(1):33-41. doi: 10.1111/wvn.12483. Epub 2020 Nov 28.
PubMed 33247619Peeters MJ, van Zuilen AD, van den Brand JA, Bots ML, van Buren M, Ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Blankestijn PJ, Wetzels JF. Nurse practitioner care improves renal outcome in patients with CKD. J Am Soc Nephrol. 2014 Feb;25(2):390-8. doi: 10.1681/ASN.2012121222. Epub 2013 Oct 24.
PubMed 24158983Manns BJ, Garg AX, Sood MM, Ferguson T, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon SN, Alam A, Allu S, Tangri N. Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.
PubMed 35314481Molnar AO, Harvey A, Walsh M, Jain AK, Bosch E, Brimble KS. The WISHED Randomized Controlled Trial: Impact of an Interactive Health Communication Application on Home Dialysis Use in People With Chronic Kidney Disease. Can J Kidney Health Dis. 2021 Jun 4;8:20543581211019631. doi: 10.1177/20543581211019631. eCollection 2021.
PubMed 34158965Sanders KA, Whited A, Martino S. Motivational interviewing for patients with chronic kidney disease. Semin Dial. 2013 Mar-Apr;26(2):175-9. doi: 10.1111/sdi.12052. Epub 2013 Feb 14.
PubMed 23406198Lunardi LE, Hill K, Xu Q, Le Leu R, Bennett PN. The effectiveness of patient activation interventions in adults with chronic kidney disease: A systematic review and meta-analysis. Worldviews Evid Based Nurs. 2023 Jun;20(3):238-258. doi: 10.1111/wvn.12634. Epub 2023 Mar 12.
PubMed 36906914Fiori KP, Rehm CD, Sanderson D, Braganza S, Parsons A, Chodon T, Whiskey R, Bernard P, Rinke ML. Integrating Social Needs Screening and Community Health Workers in Primary Care: The Community Linkage to Care Program. Clin Pediatr (Phila). 2020 Jun;59(6):547-556. doi: 10.1177/0009922820908589. Epub 2020 Mar 5.
PubMed 32131620Creswell JW. Qualitative inquiry and research design: Choosing among five approaches, 2nd ed. Thousand Oaks, CA, US: Sage Publications, Inc, 2007.
Bronfenbrenner U. Toward an experimental ecology of human development. Am Psychol. 1977;32:513-531. doi:10.1037/0003-066X.32.7.513
Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.
PubMed 3049068
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers in an Interdisciplinary Outpatient CKD Clinic to Optimize Social Care Navigation, Patient Engagement, and Home Dialysis Utilization- the CHOOSE Home Trial
- ClinicalTrials.gov ID
- NCT06925776
- Acronym / sponsor ID
- CHOOSE Home / 2025-16868
- Conditions
- Kidney Replacement Therapy
- Keywords
- Community Health Worker, Interdisciplinary Care, Kidney Replacement Therapy, home dialysis, Health-Related Social Needs, patent engagement, Hemodialysis, home hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York University
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching aims of the study are to 1) utilize a community- engaged approach with input from diverse community partners to refine the CHOOSE Home Trial; and 2) evaluate the feasibility, acceptability, and possible effect of the CHOOSE Home Intervention. Feasibility and acceptability will be evaluated using complementary quantitative and qualitative measures and organized into the dimensions of the RE-AIM framework. The investigator team hypothesizes that the CHOOSE Home intervention may lead to increased home dialysis utilization by more effectively addressing health-related social needs and fostering greater patient engagement. This proposal brings together experts in CKD care, SDOH, health equity, implementation and community-engaged research. The results will be used to inform further studies in CKD care delivery to reduce health inequities in home dialysis use and improve the quality of life for patients with CKD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, pragmatic, randomized, parallel two-arm single site trial
| Arm | Type | Receives |
|---|---|---|
| CHW facilitated social care navigation and peer support as part of IDC | Other | Other: CHOOSE Home InterventionPatients 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. |
| IDC alone | Other | Other: Usual CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOOSE Home InterventionAlso: CHW Intervention, CHW + IDC Intervention, IDC + CHWIntegration 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. | Other | CHW facilitated social care navigation and peer support as part of IDC |
| Usual CareAlso: Control GroupThis 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. | Other | IDC alone |
Primary outcome
Selection or Initiation of Home Dialysis
Time frame: 1 year study follow up period
The percentage of patients who select or initiate home dialysis in each study arm will be summarized by study arm. To account for patients who may not progress to end-stage kidney disease (ESKD) within one year, this percentage will be defined as the sum of non-ESKD patients choosing home dialysis and ESKD patients who start home dialysis, divided by the total patients in each group.
2 secondary outcomes
Change in Patient Activation Measure Scores
Time frame: From baseline to 6 months and baseline to 1 year
Change in patient-reported status of Health-related social needs (HRSNs)
Time frame: From baseline to 6 months and baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- BackgroundUnited States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022.
- Background: PubMed 25506238Francois K, Bargman JM. Evaluating the benefits of home-based peritoneal dialysis. Int J Nephrol Renovasc Dis. 2014 Dec 4;7:447-55. doi: 10.2147/IJNRD.S50527. eCollection 2014.
- Background: PubMed 35479194Johns TS, Prudhvi K, Motechin RA, Sedaliu K, Estrella MM, Stark A, Bauer C, Golestaneh L, Boulware LE, Melamed ML. Interdisciplinary Care and Preparedness for Kidney Failure Management in a High-Risk Population. Kidney Med. 2022 Mar 17;4(5):100450. doi: 10.1016/j.xkme.2022.100450. eCollection 2022 May.
- Background: PubMed 26458811Johns TS, Yee J, Smith-Jules T, Campbell RC, Bauer C. Interdisciplinary care clinics in chronic kidney disease. BMC Nephrol. 2015 Oct 12;16:161. doi: 10.1186/s12882-015-0158-6.
- Background: PubMed 22435951Cho EJ, Park HC, Yoon HB, Ju KD, Kim H, Oh YK, Yang J, Hwang YH, Ahn C, Oh KH. Effect of multidisciplinary pre-dialysis education in advanced chronic kidney disease: Propensity score matched cohort analysis. Nephrology (Carlton). 2012 Jul;17(5):472-9. doi: 10.1111/j.1440-1797.2012.01598.x.
- Background: PubMed 33247619Hsu HT, Chiang YC, Lai YH, Lin LY, Hsieh HF, Chen JL. Effectiveness of Multidisciplinary Care for Chronic Kidney Disease: A Systematic Review. Worldviews Evid Based Nurs. 2021 Feb;18(1):33-41. doi: 10.1111/wvn.12483. Epub 2020 Nov 28.
- Background: PubMed 24158983Peeters MJ, van Zuilen AD, van den Brand JA, Bots ML, van Buren M, Ten Dam MA, Kaasjager KA, Ligtenberg G, Sijpkens YW, Sluiter HE, van de Ven PJ, Vervoort G, Vleming LJ, Blankestijn PJ, Wetzels JF. Nurse practitioner care improves renal outcome in patients with CKD. J Am Soc Nephrol. 2014 Feb;25(2):390-8. doi: 10.1681/ASN.2012121222. Epub 2013 Oct 24.
- Background: PubMed 35314481Manns BJ, Garg AX, Sood MM, Ferguson T, Kim SJ, Naimark D, Nesrallah GE, Soroka SD, Beaulieu M, Dixon SN, Alam A, Allu S, Tangri N. Multifaceted Intervention to Increase the Use of Home Dialysis: A Cluster Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Apr;17(4):535-545. doi: 10.2215/CJN.13191021. Epub 2022 Mar 21.
- Background: PubMed 34158965Molnar AO, Harvey A, Walsh M, Jain AK, Bosch E, Brimble KS. The WISHED Randomized Controlled Trial: Impact of an Interactive Health Communication Application on Home Dialysis Use in People With Chronic Kidney Disease. Can J Kidney Health Dis. 2021 Jun 4;8:20543581211019631. doi: 10.1177/20543581211019631. eCollection 2021.
- Background: PubMed 23406198Sanders KA, Whited A, Martino S. Motivational interviewing for patients with chronic kidney disease. Semin Dial. 2013 Mar-Apr;26(2):175-9. doi: 10.1111/sdi.12052. Epub 2013 Feb 14.
- Background: PubMed 36906914Lunardi LE, Hill K, Xu Q, Le Leu R, Bennett PN. The effectiveness of patient activation interventions in adults with chronic kidney disease: A systematic review and meta-analysis. Worldviews Evid Based Nurs. 2023 Jun;20(3):238-258. doi: 10.1111/wvn.12634. Epub 2023 Mar 12.
- Background: PubMed 32131620Fiori KP, Rehm CD, Sanderson D, Braganza S, Parsons A, Chodon T, Whiskey R, Bernard P, Rinke ML. Integrating Social Needs Screening and Community Health Workers in Primary Care: The Community Linkage to Care Program. Clin Pediatr (Phila). 2020 Jun;59(6):547-556. doi: 10.1177/0009922820908589. Epub 2020 Mar 5.
- Individual participant dataSharing planned: Yes. In accordance with NIH guidelines, the study team will share data with qualified investigators whose research protocols have been approved by their institutions' Institutional Review Boards. The final dataset will include qualitative and quantitative data including anonymized transcripts, socio-demographics, medical history, social history, and clinical outcomes data. The dataset will be stripped of all personal identifiers according to HIPAA and the Common Rule. The investigator team plans to submit anonymized data to a generalist repository, Vivli, that is participating in the NIH Generalist Repository Ecosystem Initiative (GREI) so that it can be made available to other investigators under an NIH-approved data-sharing agreement that ensures that: (1) data is used only for research purposes and does not identify individual participants; (2) data is handled in a secure and confidential way; and (3) data is destroyed or returned after analyses are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanya S Johns, MD, MHS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOOSE Home Intervention in people with Kidney Replacement Therapy, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaxkyn A Mejia, BS (718-430-2064, yaxkyn.mejia@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selection or Initiation of Home Dialysis (time frame: 1 year study follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06925776, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.