Basic Needs Navigation for Diabetic Kidney Disease

Overseen By Mukoso N Ozieh, MD, MSCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical College of Wisconsin

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity. The study objective will be achieved with the following aims: Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity. Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention. Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.

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 data supports the effectiveness of the treatment 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 barriers. Additionally, individualized interventions tailored to personal goals and needs have been shown to improve diabetes self-management. ^{1 2 3 4 5}

Is the Basic Needs Navigation for Diabetic Kidney Disease treatment safe for humans?

The research articles provided do not contain specific safety data for the Basic Needs Navigation treatment or its related interventions. However, they suggest that individualized coaching and lifestyle interventions, which are part of the treatment, are generally safe and beneficial for managing diabetes and related conditions. ^{1 2 5 6 7}

How is the Basic Needs Navigation for Diabetic Kidney Disease treatment different from other treatments?

This treatment is unique because it combines individualized basic needs navigation with lifestyle coaching and skills training, focusing on addressing patients' specific needs and concerns, such as financial issues and social relationships, which are often not covered in traditional treatments for diabetic kidney disease. ^{8 9 10 11 12}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Enhanced usual care (Behavioural Intervention)
• Individualized basic need navigation and lifestyle coaching (Behavioural Intervention)
• Individualized basic need navigation and lifestyle coaching and skills training (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 '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]

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]

References

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

Diabetes: Health Literacy Education Improves Veteran Outcomes. [2020]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Health coaching in diabetes: empowering patients to self-manage. [2013]

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

Coping skills training in a telephone health coaching program for youth at risk for type 2 diabetes. [2021]

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

Facilitating treatment adherence with lifestyle changes in diabetes. [2006]

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

Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Effects of an individual intensive educational control program for insulin-dependent diabetic subjects with poor metabolic control. [2022]

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

Perceived informational needs, problems, or concerns among patients with stage 4 chronic kidney disease. [2015]

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

Nursing Intervention Aimed at Improving Self-Managementfor Persons with Chronic Kidney Disease in North Carolina Medicaid: A Pilot Project. [2023]

10. England 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. [2022]

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

Identifying Needs for Self-management Interventions for Adults With CKD and Their Caregivers: A Qualitative Study. [2022]

12. Canada 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. [2023]