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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline ldl at 6 months post intervention follow-up
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1c (HbA1c)
Secondary outcome measures
LDL cholesterol
Quality of Life (QOL)
Self-Care Behavior
+1 moreTrial 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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,483 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,395 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have severe mental health issues that affect your thoughts and behavior.You have been identified as having one or more challenges related to your health and well-being using a specific screening tool.I do not have type 2 diabetes or chronic kidney disease.I am 18 years old or older.I have been diagnosed with cognitive impairment.You are currently struggling with alcohol or drug abuse.I have type 2 diabetes with an HbA1c level of 8 or higher.I have chronic kidney disease.I am under 18 years old.You are not expected to live for more than 12 months.I cannot communicate in English.You are currently participating in another trial for diabetes or chronic kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment ongoing for this scientific experiment?
"As per information hosted by clinicaltrials.gov, this medical study is actively recruiting individuals to participate. The initial posting was on August 1st 2022 and the trial data has been updated as recently as August 24th 2022."
Answered by AI
What is the current participation rate of this trial?
"Affirmative. According to clinicaltrials.gov, recruitment for this experiment is still in progress and began on August 1st 2022. The most recent update was done on the 24th of August with a requirement of 100 participants at one location."
Answered by AI
Has the FDA sanctioned individualized basic need navigation and lifestyle coaching as an acceptable practice?
"Our team at Power allocated a rating of 2 to Individualized basic need navigation and lifestyle coaching due to the lack of evidence supporting efficacy, yet some data showing safety."
Answered by AI
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