Thinking of joining a study?

Register your interest

NCT05370014 | Recruiting | SARS- CoV-2


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

University of South Carolina

Information provided by (Responsible Party):

Gayenell S. Magwood

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.

Condition or disease

SARS-CoV-2

Cardiovascular Diseases

Chronic Kidney Diseases

Diabetes Mellitus, Type 2

Chronic Disease

Stroke

Intervention/treatment

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

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 500 participants
Masking : Double
Primary Purpose : Supportive Care
Official Title : Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.
Actual Study Start Date : January 3, 2023
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026
Arm Intervention/treatment

Experimental: iCINGS Fam Intervention

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.

No Intervention: Attention Control

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.

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • COVID-19 survivor inclusion criteria
  • African American
  • Male and female
  • Living in a Medically Underserved Area of South Carolina; rural
  • ≥ 18 years and above
  • A history of a COVID-19-associated hospitalization 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 same property or community preferably within 20-mile radius as the survivor
  • Primarily responsible for care provision/ care support in the home (i.e., is not paid for services)
Exclusion Criteria
  • Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, South Carolina

University of South Carolina

Columbia, South Carolina, United States, 29208

Loading...