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

Primary Purpose

SARS- CoV-2, Cardiovascular Diseases, Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for SARS- CoV-2 focused on measuring health inequities, rural, Black/African American, dyads, structural determinants of health, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCINGS Fam Intervention

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in PROMIS Short Form v1.0 Anxiety
Anxiety 6a (6 items)
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Change in PROMIS Short Form v1.0 Fatigue
Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
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.
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.
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
Change in Dyadic Efficacy
PROMIS v1.0 General Self-efficacy Scale (10 items)
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.

Full Information

First Posted
April 14, 2022
Last Updated
May 18, 2023
Sponsor
University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05370014
Brief Title
Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads
Official Title
Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS- CoV-2, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Chronic Disease, Stroke
Keywords
health inequities, rural, Black/African American, dyads, structural determinants of health, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCINGS Fam Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale
Description
Quality of Life 10 items. minimum score 4 to maximum score 20. Higher scores mean better.
Time Frame
0, 4, 7 months
Secondary Outcome Measure Information:
Title
Change in PROMIS Short Form v1.0 Anxiety
Description
Anxiety 6a (6 items)
Time Frame
0, 4, 7 months. minimum score 6 to maximum score 30. lower scores mean better.
Title
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Depression 20 items. minimum score 0 to maximum score 60. lower scores mean better.
Time Frame
0, 4, 7 months
Title
Change in PROMIS Short Form v1.0 Fatigue
Description
Fatigue 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Time Frame
0, 4, 7 months
Title
Change in PROMIS Short From v1.0 Sleep Disturbance
Description
Sleep Disturbance 6a (6 items). minimum score 6 to maximum score 30. lower scores mean better.
Time Frame
0, 4, 7 months
Title
Change in PROMIS Short Form v.1.1 Pain interference
Description
Pain interference 8a (8 items). minimum score 8 to maximum score 40. lower scores mean better.
Time Frame
0, 4, 7 months
Title
Change in Dyadic Illness Management Behaviors
Description
Survivor reported Self-care chronic illness Inventory (20 items); Informal carepartner contributions to self-care of chronic illness inventory 20 item
Time Frame
0, 4, 7 months
Title
Change in Dyadic Efficacy
Description
PROMIS v1.0 General Self-efficacy Scale (10 items)
Time Frame
0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.
Title
Change in Modified Medical Outcomes Study Social Support Survey Instrument (mMOS-SS)
Description
Social Support (8 items). Transformed minimum score 0 to maximum score 100. higher scores mean better.
Time Frame
0, 4, 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study PI
Phone
8037779160
Email
magwoodg@sc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Program Coordinator, MBA
Phone
(803) 576-7787
Email
prenticm@sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayenell S Magwood, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayenell S Magwood, PhD
Phone
803-777-9160
Email
magwoodg@sc.edu
First Name & Middle Initial & Last Name & Degree
Margie Prentice, MBA
Phone
8035767787
Email
prenticm@sc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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