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Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads

NCT05370014 · University of South Carolina
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Official title
Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.
About this study
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.
Eligibility criteria
Inclusion Criteria: 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) Exclusion Criteria: * Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-01-03
Estimated completion: 2026-06-30
Last updated: 2025-05-16
Interventions
Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
Primary outcomes
  • Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale (0, 4, 7 months)
Sponsor
University of South Carolina · other
With: National Institute of Nursing Research (NINR)
Contacts & investigators
ContactStudy PI · contact · magwoodg@sc.edu · 8037779160
ContactProgram Coordinator · contact · (803) 576-7787
InvestigatorGayenell S Magwood, PhD · principal_investigator, University of South Carolina
All locations (1)
University of South CarolinaRecruiting
Columbia, South Carolina, United States
Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads · TrialPath