Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathy Type 2 - Uncontrolled
Conditions
Keywords
Social risk factors
Brief summary
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 health-related social needs (HRSN).
Detailed description
Health-related social needs (HRSN) including 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 HRSN. Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews. Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN 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 HRSN. 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 HRSN.
Interventions
OTHERPatient and Community Stakeholder Interviews
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 HRSN.
OTHERCross-sectional Study Participants
Three hundred African American adults with DKD experiencing HRSN 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.
OTHERFocus Groups and Intervention Mapping
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.
Sponsors
Medical College of Wisconsin
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. self- report as AA/Black 2. age ≥18 3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool 4. self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD) 5. able to communicate in English.
Exclusion criteria
1. cognitive impairment at screening visit 2. active psychosis 3. active alcohol or drug abuse/dependency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (SBP) | Baseline | Blood pressure readings will be obtained using automated BP monitors |
| Hemoglobin A1c (HbA1c) | Baseline | Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c. |
| LDL cholesterol | Baseline | Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol. |
| Quality of Life (QOL) | Baseline | Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. This 12-item scale is a valid and reliable instrument of functional status and provides a summary physical health-related quality of life (PCS) and mental health-related quality of life (MCS). Scores for each of the PCS and MCS range from 0 to 100, with higher scores indicating better physical and mental health-related quality of life, respectively. |
| Self-Care Behavior | Baseline | Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale. This is an 11-item self-reported questionnaire including items assessing diet, exercise, blood glucose test, foot care, and smoking status. Higher scores indicate more engagement in self-care behaviors. |
Countries
United States
Contacts
CONTACTMukoso N Ozieh, MD, MSCR
PRINCIPAL_INVESTIGATORMukoso N Ozieh, MD, MSCR
Medical College of Wisconsin
Outcome results
None listed