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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05370014

Collaborator

National Institute of Nursing Research (NINR) (NIH)

500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS- CoV-2 Cardiovascular Diseases Chronic Kidney Diseases Diabetes Mellitus, Type 2 Chronic Disease Stroke	Behavioral: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iCINGS Fam Intervention 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.	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.
No Intervention: Attention Control 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 and Medical University of South Carolina (MUSC) Epidemiology Intelligence Project 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.

Arm

Intervention/Treatment

Experimental: iCINGS Fam Intervention

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.

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.

No Intervention: Attention Control

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 and Medical University of South Carolina (MUSC) Epidemiology Intelligence Project 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.

Outcome Measures

Primary Outcome Measures

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

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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)