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

University of South Carolina

Status: Enrolling

Conditions: Chronic Kidney Diseases; Chronic Disease; Stroke; SARS- CoV-2; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05370014

Pro00110062

1R01NR020127-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

iCINGS Fam Intervention

Experimental group

Description:

Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) is 14-week, nurse coordinated, Community Health Worker (CHW) supported telehealth intervention structure. After baseline assessment, dyads randomized to the intervention group (n= 125 dyads) will have two planning sessions (over 2 weeks) followed by eight topic-guided sessions delivered by a member of the RN-CHW team over 12 weeks (weekly the first 4 weeks, then bi-weekly), Follow up assessments will occur at month 4 and month 7.

Treatment:

Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)

Attention Control

No Intervention group

Description:

After baseline assessment, dyads randomized to the attention control group (n= 125 dyads) will receive monthly (3 in total; 7-10 min each) scripted phone calls on focused on general health risks and health promotion. Monthly telephone calls will cover readily accessible evidence-based public health messaging from the Centers for Disease Control and Prevention (CDC) Your Health, NIH and other public health community facing websites related to COVID-19 mitigation such as risk reduction and prevention strategies including flu vaccines, asymptomatic spread, and contact tracing. Follow up assessments will occur at month 4 and month 7.