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.

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Stroke; Diabetes Mellitus, Type 2; Chronic Kidney Diseases; Chronic Disease; SARS- CoV-2
• Intervention / Treatment: Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)

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
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study PI; Phone Number: 8037779160; Email: magwoodg@sc.edu
• Study Contact Backup: Name: Program Coordinator; Phone Number: (803) 576-7787

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Gayenell S Magwood, PhD; Phone Number: 803-777-9160; Email: magwoodg@sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale	Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.	0, 4, 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS Short Form v1.0 Anxiety	Anxiety 6a (6 items)	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)	Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.	0, 4, 7 months
Change in PROMIS Short Form v1.0 Fatigue	Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.	0, 4, 7 months
Change in PROMIS Short From v1.0 Sleep Disturbance	Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.	0, 4, 7 months
Change in PROMIS Short Form v.1.1 Pain interference	Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.	0, 4, 7 months
Change in Dyadic Illness Management Behaviors	Survivor reported Self-care chronic illness Inventory (20 items); Informal carepartner contributions to self-care of chronic illness inventory 20 item	0, 4, 7 months
Change in Dyadic Efficacy	PROMIS v1.0 General Self-efficacy Scale (10 items)	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)	Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.	0, 4, 7 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Gayenell S Magwood, PhD, University of South Carolina

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; rural; Black/African American; health inequities; dyads; structural determinants of health
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Chronic Disease
• Other Study ID Numbers: Pro00110062; 1R01NR020127-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No