366 Participants Needed

Community Health Interventions for Renal Disease

(INSPIRE Trial)

Recruiting at 2 trial locations
LC
Overseen ByLili Chan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Community Health Worker Assistance for renal disease?

Community health worker (CHW) interventions have been shown to improve health outcomes for Latinx individuals with kidney disease by building trust, enabling self-help, and using a trauma-informed approach. Additionally, CHWs have been effective in helping patients with diabetes and hypertension manage their conditions, suggesting they can also support people with kidney disease.12345

Is the Community Health Worker Assistance intervention safe for humans?

Community Health Worker interventions have been used safely in various health programs, including those for heart disease, stroke, and diabetes, with no specific safety concerns reported in the research.678910

How does the Community Health Worker intervention differ from other treatments for renal disease?

This treatment is unique because it involves community health workers (CHWs) who provide culturally relevant support and education, helping patients navigate the healthcare system and access resources, which is particularly beneficial for Latinx populations at higher risk for kidney disease. Unlike traditional medical treatments, this approach focuses on building trust and empowering patients to manage their health more effectively.12111213

What is the purpose of this trial?

This is a cluster randomized controlled clinical trial evaluating the effect of community health workers (CHWs) and provider education on kidney transplant (KTx) waitlisting compared to usual care (waitlist control). CKD/HD providers will be randomized to intervention or control, and all patients with the same providers will be in the same randomization group. CHWs will address unmet social needs and patient symptoms through evaluations and linkage to clinical and community services. Intervention providers will receive education, which will include training on working with CHWs, reducing bias in clinical decision-making, and increasing affirming/reducing stigmatizing language in electronic health records (EHRs).

Research Team

LC

Lili Chan

Principal Investigator

Ichan School of Medicine at Mount Sinai Hospital

Eligibility Criteria

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
See 4 more

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
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment3 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 SupportExperimental Treatment2 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.

Find a Clinic Near You

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+

Findings from Research

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.
Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology.Novick, TK., Cervantes, L., Golestaneh, L., et al.[2023]
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.
Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention.Novick, TK., Barrios, F., Osuna, M., et al.[2023]
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.
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]

References

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. [2023]
Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention. [2023]
Community health workers assisting patients with diabetes in self-management. [2012]
Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. [2022]
An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. [2022]
Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]
7.Trinidad and Tobagopubmed.ncbi.nlm.nih.gov
Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. [2023]
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. [2022]
Outcome effectiveness of community health workers: an integrative literature review. [2022]
10.United Statespubmed.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. [2022]
Barriers and Facilitators of Engaging Community Health Workers in Non-Communicable Disease (NCD) Prevention and Control in China: A Systematic Review (2006⁻2016). [2019]
The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. [2022]
Effectiveness of community health workers in the care of people with hypertension. [2022]
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