Mixed-Methods Study of Multidimensional Adversity in Inner-City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing multidimensional adversity (MDA) and living in the inner-city.

Detailed Description
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Multidimensional adversity (MDA), defined as having three or more social adversities such as loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing MDA and living in the inner-city. Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing MDA and living in the inner-city using in-depth patient and stakeholder interviews. Aim 2 (Quantitative): Examine the effect of increasing burden of MDA on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing MDA and living in the inner-city. Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing MDA and living in the inner-city.

Official Title
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Mixed-Methods Study of Multidimensional Adversity in Inner- City African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Conditions
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Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases

Intervention / Treatment
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* Other: Patient and Community Stakeholder Interviews
* Other: Cross-sectional Study Participants
* Other: Focus Groups and Intervention Mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self- report as AA/Black age ≥18 screen positive for 3 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool diagnosed type 2 diabetes (T2DM) with HbA1c≥8 chronic kidney disease (CKD) able to communicate in English. Exclusion Criteria: end stage renal disease on dialysis cognitive impairment at screening visit active psychosis active alcohol or drug abuse/dependency life expectancy <12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aim 1<br>Qualitative Aim | Other: Patient and Community Stakeholder Interviews<br>* Thirty in-depth face-to-face patient interviews, and ten in-depth structured stakeholder interviews will be conducted to explore and identify facilitators and barriers to self-care in African American adults with DKD experiencing MDA and living in the inner-city.<br>|
| Aim 2<br>Quantitative Aim | Other: Cross-sectional Study Participants<br>* Three hundred African American adults with DKD experiencing MDA and living in the inner-city will be recruited to participate in a cross-sectional study. All participants will complete a one-time survey, and blood samples and blood pressure readings will be obtained to assess clinical outcomes.<br>|
| Aim 3<br>Integrative Aim | Other: Focus Groups and Intervention Mapping<br>* A subsample of patient interview/cross-sectional study participants will be invited back to participate in four focus groups (five participants/group) to review components of the intervention, give feedback on appropriateness, feasibility, acceptability, and likelihood of having an impact based on their lived experiences.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) | Blood pressure readings will be obtained using automated BP monitors | Baseline | 
| Hemoglobin A1c (HbA1c) | Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c. | Baseline | 
| LDL cholesterol | Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol. | Baseline | 
| Quality of Life (QOL) | Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. | Baseline | 
| Self-Care Behavior | Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social risk factors