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Идёт набор NCT05692388

Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Patient and Community Stakeholder Interviews, Cross-sectional Study Participants, Focus Groups and Intervention Mapping.
Кому может быть актуально
Состояния в реестре: Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое Patient 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.
  • Другое Cross-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.
  • Другое Focus 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.

Первичные конечные точки

  • Systolic blood pressure (SBP) [Срок оценки: Baseline]
  • Hemoglobin A1c (HbA1c) [Срок оценки: Baseline]
  • LDL cholesterol [Срок оценки: Baseline]
  • Quality of Life (QOL) [Срок оценки: Baseline]
  • Self-Care Behavior [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • self- report as AA/Black
  • age ≥18
  • 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.

Критерии исключения

  • cognitive impairment at screening visit
  • active psychosis
  • active alcohol or drug abuse/dependency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT05692388 · PRO00043301 · 1K23MD016448-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗