Community Health Interventions for Renal Disease

(INSPIRE Trial)

Recruiting at 2 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

366 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 11 12 13}

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

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

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

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

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+

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.

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]

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]

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 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]

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]

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) 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Proceedings of a Workshop to Promote Community Health Worker Interventions in Nephrology. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitating Medical Care for Latinx Individuals at Risk for CKD: A Pilot Intervention. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Community health workers assisting patients with diabetes in self-management. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. [2022]

5. India 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]

7. Trinidad and Tobago pubmed.ncbi.nlm.nih.gov

Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. [2023]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States 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. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Engaging Community Health Workers in Non-Communicable Disease (NCD) Prevention and Control in China: A Systematic Review (2006⁻2016). [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The Value of Community Health Workers in Diabetes Management in Low-Income Populations: A Qualitative Study. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. [2022]