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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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)

Критерии исключения

• Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of South Carolina — Columbia

Публикации

• 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

Идентификаторы

NCT: NCT05370014 · Pro00110062 · 1R01NR020127-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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