Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads
- Conditions
- Cardiovascular DiseasesChronic Kidney DiseasesChronic DiseaseSARS- CoV-2Diabetes Mellitus, Type 2Stroke
- Interventions
- Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
- Registration Number
- NCT05370014
- Lead Sponsor
- University of South Carolina
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
COVID-19 survivor inclusion criteria
-
African American
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Male and female
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Living in a Medically Underserved Area and/or a designated rural area of South Carolina
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≥ 18 years and above
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A history of a COVID-19-associated hospitalization, ER or Urgent Care visit since March 11th, 2020
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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
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Must live on the same property or community, preferably within a 40-mile radius of the survivor
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Primarily responsible for care provision and/or care/social support in the home (i.e., is not paid for services)
- Survivor and Carepartner exclusion criteria • Enrolled in related clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iCINGS Fam Intervention Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) 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.
- Primary Outcome Measures
Name Time Method Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale 0, 4, 7 months Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.
- Secondary Outcome Measures
Name Time Method Change in PROMIS Short From v1.0 Sleep Disturbance 0, 4, 7 months Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Change in PROMIS Short Form v.1.1 Pain interference 0, 4, 7 months Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.
Change in Dyadic Illness Management Behaviors 0, 4, 7 months Survivor reported Self-care chronic illness Inventory (20 items); Informal carepartner contributions to self-care of chronic illness inventory 20 item
Change in PROMIS Short Form v1.0 Anxiety 0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better. Anxiety 6a (6 items)
Change in Center for Epidemiologic Studies Depression Scale (CES-D) 0, 4, 7 months Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Change in PROMIS Short Form v1.0 Fatigue 0, 4, 7 months Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Change in Dyadic Efficacy 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better. PROMIS v1.0 General Self-efficacy Scale (10 items)
Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS) 0, 4, 7 months Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.
Trial Locations
- Locations (1)
University of South Carolina
🇺🇸Columbia, South Carolina, United States