Community Health Interventions for Renal Disease

(INSPIRE Trial)

Recruiting at 3 trial locations

Overseen By Lili Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Dementia, Active malignancy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 18

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether community health workers (CHWs) and provider education can help more people with kidney disease join the transplant waitlist. It focuses on patients with very low kidney function or those on regular dialysis, treated at specific hospitals in New York City. Patients needing community support who speak English or Spanish may find this trial suitable. The study compares two groups: one receiving extra help from CHWs and educated providers, and the other receiving usual care. As an unphased trial, this study offers patients a chance to contribute to innovative approaches in healthcare support and education.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this protocol is safe for kidney transplant patients?

Research has shown that community health workers (CHWs) are safe and helpful in caring for people with kidney disease. A workshop on CHW programs for kidney health found that these workers meet patients' social needs without causing harm, and no major negative effects were reported.

The program includes training healthcare providers to work with CHWs and enhance communication. This training is safe, as it involves no physical treatment. It aims to improve understanding and reduce bias in patient care.

Overall, using CHWs and training providers in kidney transplant support is considered safe based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker Assistance in kidney transplant support because it offers a personalized approach that current standard treatments lack. This method focuses on patient education about the transplant process and provides personalized assistance through community health workers, which is not typically part of usual care. By connecting patients with necessary social services, this approach aims to address social determinants of health, potentially leading to better transplant outcomes and improved patient engagement.

What evidence suggests that this trial's interventions could be effective for improving kidney transplant waitlisting?

This trial will compare the effectiveness of two approaches: one where participants receive assistance from community health workers (CHWs) and intervention providers, and another where participants receive usual care. Studies have shown that using CHWs and educating healthcare providers helps more patients get on the kidney transplant waiting list. Research indicates that CHWs can reduce health disparities, especially for racial and ethnic minorities with kidney disease, by connecting patients with necessary services and guiding them through the transplant process. Educating healthcare providers to collaborate with CHWs and reduce biases also improves patient outcomes. Initial findings suggest these combined efforts can make the transplant process more accessible and fair. ^{2 6 7 8 9}

Who Is on the Research Team?

Lili Chan

Principal Investigator

Ichan School of Medicine at Mount Sinai Hospital

Are You a Good Fit for This Trial?

This trial is for patients with renal disease who are under the care of CKD/HD providers. Participants will be grouped based on their provider's random assignment to either the intervention or control group. The study aims to help those facing social challenges that affect their health.

Inclusion Criteria

Patient must receive kidney care at Mount Sinai, Einstein, Bellevue Hospital, NYU, or hemodialysis at a participating HD Center

Patient must be community dwelling (not in a nursing home or currently incarcerated)

Provider must provide signed and dated informed consent

Exclusion Criteria

Provider must be planning to leave their respective institutions in the next 1 year

Patient must have been previously evaluated by KTx and not listed for specific medical reasons

Patient must already be listed for KTx

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive support from community health workers and provider education to assist with the kidney transplant process

24 months

Baseline, and then every 6 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

12 months after first study visit

Extension

Participants in the usual care group receive education and limited CHW support at the end of the study

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker Assistance
• Intervention Providers

Trial Overview The trial is testing if support from community health workers and additional education for kidney transplant providers can increase the number of patients getting on a transplant waitlist, compared to usual care without this extra support.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 3 Interventions

Participants will receive usual care and at the end of the study will receive education, and work with CHWs in a more limited capacity. Control clinicians will receive the education intervention.

Group II: Community Health Worker and Intervention Providers-Assisted Kidney Transplant Support Experimental Treatment 2 Interventions

Participants will receive assignment to a community health worker who will educate them on the kidney transplant process, assist them through the kidney transplant process and connect them with any necessary social services.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Promotoras who delivered a healthy lifestyle intervention showed significant improvements in their health, including reductions in systolic and diastolic blood pressure and body mass index over a 6-month period.

This study highlights the positive impact of health interventions on promotoras themselves, suggesting that empowering community health workers can enhance their own health while they promote healthy behaviors in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. Madanat, H., Martinez, A., Molina, M., et al.[2023]

A 12-month home-based intervention led by community health workers (CHWs) did not significantly lower HbA1c levels for the overall group of low-income adults with diabetes compared to usual care, indicating limited efficacy in the general population.

However, for participants with very high HbA1c levels (greater than 10%), the intervention resulted in a significant decrease in HbA1c, suggesting that CHW support may be particularly beneficial for those with poor glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Community Health Worker Self-Management Support Intervention Among Low-Income Adults With Diabetes, Seattle, Washington, 2010-2014. Nelson, K., Taylor, L., Silverman, J., et al.[2022]

Structured health education for community health workers significantly improved hypertensive patients' knowledge about hypertension, leading to better medication adherence, which increased from 20% to 70%.

The intervention also resulted in a notable improvement in low salt diet compliance among patients, rising from 39% to 85%, while the control group showed no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. Lukitasari, M., Nugroho, DA., Rohman, MS., et al.[2022]

Community health workers (CHWs) significantly improve blood pressure control in patients, as shown in seven out of eight randomized controlled trials (RCTs) reviewed, particularly among underserved urban African American populations.

CHWs also enhance self-management behaviors related to hypertension, such as medication adherence and appointment attendance, indicating their valuable role in multidisciplinary healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. Brownstein, JN., Chowdhury, FM., Norris, SL., et al.[2022]

Community health workers (CHWs) played a crucial role in a diabetes self-management intervention for low-income individuals, addressing barriers such as lack of diabetes knowledge, socioeconomic challenges, and healthcare system complexity through personalized education and support.

The study analyzed 634 encounter reports from 145 participants, highlighting that CHWs provided essential resources and guidance, demonstrating their effectiveness in improving diabetes management beyond what typical primary care can offer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. Silverman, J., Krieger, J., Sayre, G., et al.[2022]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

Community health workers (CHWs) significantly improve care quality and health outcomes for chronic diseases, particularly hypertension, by enhancing access to care and treatment adherence among underserved populations.

CHWs play vital roles in patient education, monitoring health, and facilitating communication between patients and providers, but challenges remain in integrating them into healthcare teams effectively, requiring sustainable funding and policy changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. Brownstein, JN., Bone, LR., Dennison, CR., et al.[2022]

Latinx populations experience higher rates of kidney failure compared to non-Latinx Whites, despite similar rates of chronic kidney disease (CKD), highlighting the need for targeted interventions.

Community health worker (CHW) programs can improve outcomes for Latinx individuals with kidney disease by building trust, allowing participant input, and using trauma-informed approaches, but face challenges like systemic barriers and low recruitment, necessitating further research on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. Novick, TK., Cervantes, L., Golestaneh, L., et al.[2023]

Community health workers (CHWs) have shown preliminary effectiveness in increasing access to healthcare, especially in underserved populations, according to a review of existing literature.

However, the impact of CHWs on health knowledge, health outcomes, and behavior changes remains inconclusive, highlighting the need for better study designs and clearer definitions of their roles and target populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome effectiveness of community health workers: an integrative literature review. Swider, SM.[2022]

A community health worker (CHW) intervention was implemented for Latinx individuals at risk for kidney disease, showing that 41% of participants completed the program and 75% of those who engaged scheduled a primary care appointment within 180 days.

Participants reported increased access to healthcare and improved navigation of the medical system, highlighting the intervention's acceptability and potential to address health disparities in kidney care among Latinx communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention. Novick, TK., Barrios, F., Osuna, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257810/

Culturally Concordant Community-Health Workers CHW interventions are a promising community-based approach to reduce kidney health disparities for racial and ethnic minorities and people that experience ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06655857

Interventions for Promoting Kidney Transplant ... This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant ...

3. journals.lww.com journals.lww.com/jasn/fulltext/2023/11000/proceedings_of_a_workshop_to_promote_community.6.aspx

Proceedings of a Workshop to Promote Community Health... We convened a workshop of four ongoing kidney disease CHW programs to identify successes, challenges, potential solutions, and needed research.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925006114

Expanding Kidney Care: How Non-Physician Health ... For APPs, this may include prescribing and comprehensive disease management, while for community health workers, the focus may be on screening, ...

5. reporter.nih.gov reporter.nih.gov/project-details/11126805

A Multi-Level Intervention to Reduce Kidney Health Disparities Compared to non-Latinx Whites, they are less likely to start recommended kidney replacement therapy (KRT) such as home dialysis and kidney transplant. Reducing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10631597/

Proceedings of a Workshop to Promote Community Health ... We convened a workshop of four ongoing kidney disease CHW programs to identify successes, challenges, potential solutions, and needed research.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469606/

Interventions to Address Health-Related Social Needs ... From 1990 to 2017, the number of people with kidney failure initiating dialysis or receiving a kidney transplant increased by 43.1% and 34.4%, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0272638625007693

Population Health Management for Improving Kidney ... A thoughtfully designed population health management approach, that leverages electronic health record, can modernize CKD care delivery and improve outcomes.

9. tandfonline.com tandfonline.com/doi/full/10.1080/0886022X.2025.2513007

Health insurance and kidney transplantation outcomes in ... Publicly insured recipients had higher post-transplant mortality and graft failure rates. Loss of Medicare after 36 months was associated with reduced ...