跳至主要内容
临床试验/NCT05370014
NCT05370014招募中不适用

Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

University of South Carolina2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

研究概览

简要总结

This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2 )(COVID-19) in African American (AA) adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and Black/African American from rural regions are burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke.

详细描述

This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of SARS- CoV-2 (COVID-19) in African American (AA) adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and Black/African American from rural regions are burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke. Those chronic diseases contribute to more severe health consequences and higher rates of mortality from COVID-19. POC are also more likely to be impacted by social and structural determinants of health (SSDH), such as barriers to health care access, discrimination, and lack of social support, that negatively impact quality of life (QoL) and effective chronic disease self- management behaviors. To provide the fullest health benefits to participants with chronic conditions in the wake of the COVID-19 pandemic, it is critical that we design interventions targeting SSDH for improved chronic disease self-management, health, functioning, QoL.

This study will utilize an embedded mixed methods design paired with an efficacy randomized controlled trial (RCT). Our iCINGS FAM (Integrating Community-based Intervention Under Nurse Guidance with Families) is a Registered Nurse (RN)-Community Health Worker (CHW)-delivered, telehealth intervention (14-weeks) that targets compounding racial- and pandemic-related stressors for improved chronic illness management and future disease risk mitigation in adult AA COVID-19 survivor/IC dyads.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • COVID-19 survivor inclusion criteria
  • African American
  • Male and female
  • Living in a Medically Underserved Area and/or a designated rural area of South Carolina
  • ≥ 18 years and above
  • A history of a COVID-19-associated hospitalization, ER or Urgent Care visit since March 11th, 2020
  • A previous diagnosis of one or more of the following conditions: type 2 diabetes, hypertension, cardiovascular disease, chronic kidney disease, or stroke (>3 months)
  • Carepartner inclusion criteria
  • Male and female
  • ≥ 18 years and above
  • Must live on the same property or community, preferably within a 40-mile radius of the survivor
  • Primarily responsible for care provision and/or care/social support in the home (i.e., is not paid for services)

排除标准

  • Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials

结局指标

主要结局

Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

时间窗: 0, 4, 7 months

Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.

次要结局

  • Change in PROMIS Short From v1.0 Sleep Disturbance(0, 4, 7 months)
  • Change in PROMIS Short Form v.1.1 Pain interference(0, 4, 7 months)
  • Change in Dyadic Illness Management Behaviors(0, 4, 7 months)
  • Change in PROMIS Short Form v1.0 Anxiety(0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.)
  • Change in Center for Epidemiologic Studies Depression Scale (CES-D)(0, 4, 7 months)
  • Change in PROMIS Short Form v1.0 Fatigue(0, 4, 7 months)
  • Change in Dyadic Efficacy(0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.)
  • Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS)(0, 4, 7 months)

研究者

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

Gayenell S. Magwood

Professor

University of South Carolina

研究点 (2)

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