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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05370014
Other study ID # Pro00110062
Secondary ID 1R01NR020127-01
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date June 30, 2026

Study information

Verified date June 2024
Source University of South Carolina
Contact Study PI
Phone 8037779160
Email magwoodg@sc.edu
Is FDA regulated No
Health authority
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 30, 2026
Est. primary completion date May 30, 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

Study Design


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
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