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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR020127-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCINGS Fam Intervention | Experimental | 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. |
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| Attention Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) | Behavioral | 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. |
| 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 |
| 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) |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study PI | Contact | 8037779160 | magwoodg@sc.edu | |
| Program Coordinator | Contact | (803) 576-7787 |
| Name | Affiliation | Role |
|---|---|---|
| Gayenell S Magwood, PhD | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Recruiting | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37665520 | Background | 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. | |
| 39310085 | Result | 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. |
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|
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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D002908 | Chronic Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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