NCT05370014

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS- CoV-2
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Chronic Disease
• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)	The intervention consists of two planning sessions with the dyad (over 2 weeks) followed by eight topic-guided sessions delivered the RN-CHW team over 12 weeks (weekly the first 4 weeks, then bi-weekly) (Table 3). Key components of these televisits include COVID-19 risk mitigation, chronic disease management, medication adherence, family functioning/support, and community and health systems resource identification and referral with ongoing goal planning. The RN-CHW will meet weekly for progress review, follow up planning, and setting up anticipatory guidance for the next session with the dyads. The RN and CHW will also review IC or survivor dissatisfaction and other issues that require more immediate attention. RN-CHW planning will be assessed to make sure each televisit remain topic focused yet incorporates flexibility to suit the needs of each dyad.

Timeline

• Start date: 2023-01-03
• Primary completion: 2026-05-30
• Completion: 2026-06-30
• First posted: 2022-05-11
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States