Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Self-Care Behavior
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self- report as AA/Black
- •screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
- •self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD)
- •able to communicate in English.
排除标准
- •cognitive impairment at screening visit
- •active psychosis
- •active alcohol or drug abuse/dependency
研究组 & 干预措施
Aim 2
Quantitative Aim
干预措施: Cross-sectional Study Participants (Other)
Aim 1
Qualitative Aim
干预措施: Patient and Community Stakeholder Interviews (Other)
Aim 3
Integrative Aim
干预措施: Focus Groups and Intervention Mapping (Other)
结局指标
主要结局
Self-Care Behavior
时间窗: 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.
LDL cholesterol
时间窗: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Systolic blood pressure (SBP)
时间窗: Baseline
Blood pressure readings will be obtained using automated BP monitors
Quality of Life (QOL)
时间窗: 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.
Hemoglobin A1c (HbA1c)
时间窗: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
次要结局
未报告次要终点
研究者
Mukoso N. Ozieh
Associate Professor
Medical College of Wisconsin