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临床试验/NCT05357742
NCT05357742已完成不适用

Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Feasibility of the basic needs navigation intervention

研究概览

简要总结

The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.

The study objective will be achieved with the following aims:

Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.

Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.

Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.

详细描述

Multidimensional adversity, defined as having three or more social adversities such as housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD and negatively impacts health outcomes. Evidence suggests patient navigation programs may be a promising strategy to improve health outcomes in low-income individuals with chronic disease. However, there is limited evidence on the use of patient navigator programs to address multidimensional adversity in individuals with chronic disease. Therefore, the primary objective of this study is to address this gap in knowledge.

Study overview: This will be accomplished using a two-arm pilot randomized control trial. Fifty (50) African American adults with DKD experiencing multidimensional adversity will be randomized into one of two arms: 1) Intervention arm and 2) Enhanced usual care arm.

Description of intervention: Participants randomized to the intervention arm will receive the manualized study intervention which includes three components 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training. All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).

Control arm (Enhanced usual care arm): Participants randomized to the control arm will receive the manualized study intervention which incudes only DKD education.

All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self- report as Black/African American
  • screen positive for 1 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.

排除标准

  • does not identify as Black/African American
  • no diagnosis of T2DM and CKD
  • cognitive impairment at screening visit
  • active psychosis
  • active alcohol or drug abuse/dependency
  • life expectancy <12 months
  • participation in other diabetes/CKD trials
  • unable to communicate in English.

结局指标

主要结局

Feasibility of the basic needs navigation intervention

时间窗: At 6 months post intervention follow-up

Feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention

次要结局

  • Systolic blood pressure (SBP)(Change in baseline SBP at 6 months post intervention follow-up)
  • LDL cholesterol(Change in baseline LDL at 6 months post intervention follow-up)
  • Hemoglobin A1c (Hb A1c)(Change in baseline Hb A1c at 6 months post intervention follow-up)
  • LDL cholesterol(Change in baseline LDL at 6 months post intervention follow-up)
  • Basic Needs(At 6 months post intervention follow-up)
  • Systolic blood pressure (SBP)(Change in baseline SBP at 6 months post intervention follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mukoso N. Ozieh

Assistant Professor

Medical College of Wisconsin

研究点 (2)

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