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Basic Needs Navigation for Diabetic Kidney Disease

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18

Diagnosed with type 2 diabetes (T2DM) with HbA1c≥8

Must not have

Cognitive impairment at screening visit

No diagnosis of T2DM and CKD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline ldl at 6 months post intervention follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a basic needs navigation intervention to see if it can help low-income African Americans with diabetic kidney disease who are experiencing multidimensional adversity. The study will look at feasibility, clinical outcomes, self-care behaviors, and quality of life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve non-medical support such as basic needs navigation and lifestyle coaching rather than drugs or medical procedures, typical side effects associated with medications are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have type 2 diabetes with an HbA1c level of 8 or higher.

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I have chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cognitive impairment.

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

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I am under 18 years old.

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I cannot communicate in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline hba1c at 6 months post intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline hba1c at 6 months post intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline hba1c at 6 months post intervention follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1c (HbA1c)

Secondary study objectives

LDL cholesterol

Quality of Life (QOL)

Self-Care Behavior

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 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 groupActive Control1 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.

0 / 7Eligibility criteria met