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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370014
• Other study ID #: Pro00110062
• Secondary ID: 1R01NR020127-01
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: Study PI
• Phone: 8037779160
• Email: magwoodg[@]sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

COVID-19 survivor inclusion criteria

• African American
• Male and female
• Living in a Medically Underserved Area of South Carolina; rural
• = 18 years and above
• A history of a COVID-19-associated hospitalization 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 same property or community preferably within 20-mile radius as the survivor
• Primarily responsible for care provision/ care support in the home (i.e., is not paid for services)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Disease
• Chronic Kidney Diseases
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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