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.

Overview

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.

Interventions

• 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

Primary outcome measures

• Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale [Time frame: 0, 4, 7 months]

Secondary outcome measures (8)

• Change in PROMIS Short Form v1.0 Anxiety [Time frame: 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) [Time frame: 0, 4, 7 months]
• Change in PROMIS Short Form v1.0 Fatigue [Time frame: 0, 4, 7 months]
• Change in PROMIS Short From v1.0 Sleep Disturbance [Time frame: 0, 4, 7 months]
• Change in PROMIS Short Form v.1.1 Pain interference [Time frame: 0, 4, 7 months]
• Change in Dyadic Illness Management Behaviors [Time frame: 0, 4, 7 months]
• Change in Dyadic Efficacy [Time frame: 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) [Time frame: 0, 4, 7 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of South Carolina — Columbia

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. PMID 37665520
• 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. PMID 39310085

Identifiers

NCT: NCT05370014 · Pro00110062 · 1R01NR020127-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗