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Clinical Trials/NCT05370014
NCT05370014
Recruiting
Not Applicable

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

University of South Carolina1 site in 1 country500 target enrollmentStarted: January 3, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
500
Locations
1
Primary Endpoint
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 0, 4, 7 months

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gayenell S. Magwood

Professor

University of South Carolina

Study Sites (1)

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