Basic Needs Navigation for Diabetic Kidney Disease

Overseen By Mukoso N Ozieh, MD, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Cognitive impairment, Active psychosis, Alcohol/drug abuse, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to improve the health and well-being of low-income African Americans with diabetic kidney disease. It emphasizes personalized support to meet basic needs and includes lifestyle coaching and skills training, known as "Individualized basic need navigation and lifestyle coaching and skills training." Participants will receive guidance over the phone for six months. Individuals with type 2 diabetes, high blood sugar (HbA1c≥8), chronic kidney disease, and challenges like financial or housing issues may be well-suited for this study. As an unphased trial, this study offers a unique opportunity for personalized support and potential health and well-being improvements.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this basic needs navigation intervention is safe?

Research has shown that telehealth coaching, similar to the lifestyle coaching in this study, is generally safe. Although it did not significantly change some health scores, it caused no harm.

Another study highlighted that personalized diabetes management can improve diabetes outcomes. While specific safety details for basic needs navigation treatments are not provided, this approach is well-regarded and not known to cause negative effects.

As this intervention focuses on lifestyle changes and support, serious side effects are not usually expected. However, staying informed and discussing any concerns with the research team is important for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Basic Needs Navigation for Diabetic Kidney Disease trial because it explores a holistic approach that combines lifestyle coaching with skills training, delivered via telephone. Unlike typical treatments that focus primarily on medication management, this approach emphasizes personalized support to address the social and lifestyle factors impacting health. By offering regular sessions with health educators, the program aims to empower patients to make sustainable changes, potentially leading to better long-term outcomes. This method could revolutionize care by providing more accessible and tailored support, particularly for those who face barriers to traditional healthcare services.

What evidence suggests that this trial's treatments could be effective for diabetic kidney disease?

Research has shown that health coaching, part of the Individualized Basic Need Navigation and Lifestyle Coaching treatment in this trial, can help manage diabetes by setting goals and addressing challenges. Studies have found that educational programs for people with diabetic kidney disease effectively improve blood sugar control and kidney function. A review of these studies found that such programs lead to better disease management and quality of life. Additionally, meeting basic needs, such as having enough food and stable housing, supports overall health improvements in patients. These elements suggest that the treatments tested in this trial could effectively improve health outcomes for those with diabetic kidney disease. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for African Americans over 18 with diabetic kidney disease, type 2 diabetes (HbA1c≥8), and chronic kidney disease. They must speak English and have at least one adversity as per a specific screening tool. Excluded are those with life expectancies under a year, other trial participations, cognitive impairments, no T2DM/CKD diagnosis, or active substance abuse/psychosis.

Inclusion Criteria

Able to communicate in English

Self-report as Black/African American

You have been identified as having one or more challenges related to your health and well-being using a specific screening tool.

Exclusion Criteria

You currently have severe mental health issues that affect your thoughts and behavior.

I do not have type 2 diabetes or chronic kidney disease.

I have been diagnosed with cognitive impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the manualized study intervention including DKD education, individualized basic needs navigation, and lifestyle coaching and skills training

12 weeks

Weekly telephone sessions

Booster Sessions

Participants receive three monthly booster sessions to reinforce the intervention

3 months

Monthly telephone sessions

Follow-up

Participants are monitored for changes in clinical outcomes, self-care behaviors, and quality of life

6 months

Assessments at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• Individualized basic need navigation and lifestyle coaching
• Individualized basic need navigation and lifestyle coaching and skills training

Trial Overview The study tests if personalized basic needs navigation and lifestyle coaching can improve clinical outcomes like blood sugar control (HbA1c), blood pressure, lipids; self-care behaviors; and quality of life in low-income African Americans facing multiple challenges alongside their diabetic kidney disease.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants randomized to the intervention group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention.

Group II: Control group Active Control 1 Intervention

Participants randomized to the control group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A study involving 37 participants with chronic kidney disease (CKD) identified three key needs for self-management support: empowerment through knowledge about CKD and its implications, activation through effective information sharing, and tangible support from family and healthcare professionals.

The findings suggest that enhancing self-management interventions for CKD patients could improve health outcomes by focusing on education, timely information, and community support, although the study's participant demographics may limit the generalizability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Needs for Self-management Interventions for Adults With CKD and Their Caregivers: A Qualitative Study. Donald, M., Beanlands, H., Straus, S., et al.[2022]

The 'My Kidneys & Me' program is a 10-week digital self-management intervention designed to improve patient activation in individuals with chronic kidney disease (CKD) stages 3-4, with a total of 432 participants planned for the study.

The study will assess the feasibility of the intervention and its impact on patient activation levels using the Patient Activation Measure (PAM-13), with outcomes evaluated at baseline, 10 weeks, and 20 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Self-Management Intervention through Lifestyle Education for Kidney health' (the SMILE-K study): protocol for a single-blind longitudinal randomised controlled trial with nested pilot study. Lightfoot, CJ., Wilkinson, TJ., Yates, T., et al.[2022]

Patients with Stage 4 Chronic Kidney Disease (CKD) have significant informational needs, particularly regarding understanding their kidney disease, managing prescribed medications, caring for vascular access, and addressing financial concerns.

Patients expressed a desire for educational programs to cover topics such as kidney disease knowledge, vascular access care, treatment options, and medication management, indicating a need for more comprehensive pre-dialysis education than is typically provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived informational needs, problems, or concerns among patients with stage 4 chronic kidney disease. Lewis, AL., Stabler, KA., Welch, JL.[2015]

A diabetes outreach program implemented in a hemodialysis unit in London, Ontario, successfully improved self-monitoring of diabetes among 58 participants over a 3-year period, despite challenges posed by the COVID-19 pandemic.

The program led to a modest decline in self-reported hyperglycemia without any adverse consequences, indicating its safety and potential effectiveness in enhancing diabetes care for patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Type 1 and 2 Diabetes Care in the Hemodialysis Unit: A Quality-improvement Initiative Throughout the COVID-19 Pandemic. Brahmbhatt, S., Mikalachki, A., Lawrence, JA., et al.[2023]

A study involving 402 participants at increased cardiovascular risk found that personalized e-coaching did not lead to greater reductions in pulse wave velocity (PWV) compared to standard care, indicating no added benefit from the e-coaching intervention.

Overall, while the health check program showed a modest reduction in cardiovascular risk, the results suggest that e-coaching should not be routinely recommended as part of cardiovascular health check programs, as it did not enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. Khanji, MY., Balawon, A., Boubertakh, R., et al.[2020]

The telephone health coaching intervention effectively reinforced lifestyle changes in urban adolescents at risk for type 2 diabetes mellitus (T2DM) by incorporating coping skills training, demonstrating its potential as a supportive tool for health promotion.

Vignettes used in the intervention illustrated practical applications of coping skills, highlighting the importance of tailored approaches in engaging high-risk youth and addressing their specific challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping skills training in a telephone health coaching program for youth at risk for type 2 diabetes. Jefferson, V., Jaser, SS., Lindemann, E., et al.[2021]

The pilot study highlights the effectiveness of personalized nursing interventions in improving diabetes self-management, emphasizing the importance of aligning care with individual patient goals and health needs.

These tailored approaches can lead to better health outcomes for patients with diabetes, suggesting that individualized care is a key factor in successful diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes: Health Literacy Education Improves Veteran Outcomes. Wimer, C., Shipman, D., Lea, L.[2020]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

Healthy eating and increased physical activity are crucial for preventing or delaying diabetes, and primary care can adapt techniques to help patients adhere to these lifestyle changes.

A coaching approach that includes setting specific goals, regular follow-ups, and a team-based intervention can significantly enhance patient motivation and self-sufficiency in making long-term lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating treatment adherence with lifestyle changes in diabetes. Koenigsberg, MR., Bartlett, D., Cramer, JS.[2006]

An intensive educational control program for 15 insulin-dependent diabetic patients significantly improved metabolic control, as evidenced by a sustained decrease in hemoglobin A1c levels over 24 months.

The program also enhanced patients' knowledge of diabetes and self-monitoring skills without major changes in dietary intake or insulin schedules, indicating a safe and effective approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an individual intensive educational control program for insulin-dependent diabetic subjects with poor metabolic control. Conget, I., Jansá, M., Vidal, M., et al.[2022]

The pilot project targeted Medicaid beneficiaries with Stage 3b and 4 chronic kidney disease, providing up to six educational sessions led by a nurse practitioner to enhance their knowledge and self-management skills.

Participants showed increases in knowledge and reported behavior changes, indicating that structured educational interventions can positively impact self-management in chronic kidney disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing Intervention Aimed at Improving Self-Managementfor Persons with Chronic Kidney Disease in North Carolina Medicaid: A Pilot Project. Jacobson Vann, JC., Hawley, J., Wegner, S., et al.[2023]

Effective diabetes management requires patient adherence to treatment and lifestyle changes, which is often lacking; education combined with self-management support is beneficial.

Health coaching, focusing on self-efficacy and skills like goal-setting and problem-solving, has been shown to be highly effective in improving diabetes self-management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching in diabetes: empowering patients to self-manage. Wong-Rieger, D., Rieger, FP.[2013]

Citations

1. withpower.com withpower.com/trial/phase-kidney-diseases-4-2022-c2dfe

Basic Needs Navigation for Diabetic Kidney Disease Research shows that health coaching, which is part of the treatment, can be effective for diabetes management by helping patients set goals and overcome ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/372095

Basic Needs Navigation Intervention to Address ... The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11339929/

Education programmes for people with chronic kidney ... Basic need navigation intervention to address unmet basic needs in African Americans with diabetic kidney disease [Basic needs navigation ...

4. rrtjournal.biomedcentral.com rrtjournal.biomedcentral.com/articles/10.1186/s41100-024-00554-y

Effectiveness of educational programs for patients with ... The purpose of this study was to conduct a systematic review and meta-analysis to identify effective educational programs for diabetic kidney disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629034/

Long-Term Efficacy of an AI-Based Health Coaching ... This study aimed to evaluate the long-term efficacy of the KidneyOnline intelligent care system in slowing the progression of nondialysis-dependent CKD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05357742

NCT05357742 | Basic Needs Navigation Intervention to Address ... The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7057309/

A Coaching Program to Improve Dietary Intake of Patients ... Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in ...

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15476

What is meant by 'integrated personalized diabetes ... Integrated personalized diabetes management (IPDM) has emerged as a promising approach to improving outcomes in patients with diabetes mellitus (DM).