Clinical trial NCT05370014: Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads
Official title: Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SARS- CoV-2
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus, Type 2
Chronic Disease
Stroke
Keywords: health inequities
rural
Black/African American
dyads
structural determinants of health
quality of life
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-05-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale
timeFrame: 0, 4, 7 months
Secondary outcomes:
measure: Change in PROMIS Short Form v1.0 Anxiety
timeFrame: 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 0, 4, 7 months
measure: Change in PROMIS Short Form v1.0 Fatigue
timeFrame: 0, 4, 7 months
measure: Change in PROMIS Short From v1.0 Sleep Disturbance
timeFrame: 0, 4, 7 months
measure: Change in PROMIS Short Form v.1.1 Pain interference
timeFrame: 0, 4, 7 months
measure: Change in Dyadic Illness Management Behaviors
timeFrame: 0, 4, 7 months
measure: Change in Dyadic Efficacy
timeFrame: 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.
measure: Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS)
timeFrame: 0, 4, 7 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Gayenell S Magwood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott J, Burrison S, Barron M, Logan A, Magwood GS. Exploring Nursing Strategies to Engage Community in Cardiovascular Care. Curr Cardiol Rep. 2023 Oct;25(10):1351-1359. doi: 10.1007/s11886-023-01949-9. Epub 2023 Sep 4.
citation: Magwood GS, Ellis C Jr, Hughes Halbert C, Toussaint EA, Scott J, Nemeth LS. Exploring Barriers to Effective COVID-19 Risk Mitigation, Recovery, and Chronic Disease Self-Management: A Qualitative Multilevel Perspective. Patient Relat Outcome Meas. 2024 Sep 18;15:241-253. doi: 10.2147/PROM.S467743. eCollection 2024.