Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads
2 other identifiers
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
January 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 16, 2025
May 1, 2025
3.4 years
April 14, 2022
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change in PROMIS Short Form v1.0 Anxiety
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)
0, 4, 7 months
Change in PROMIS Short Form v1.0 Fatigue
0, 4, 7 months
Change in PROMIS Short From v1.0 Sleep Disturbance
0, 4, 7 months
Change in PROMIS Short Form v.1.1 Pain interference
0, 4, 7 months
- +3 more secondary outcomes
Study Arms (2)
iCINGS Fam Intervention
EXPERIMENTALIntegrating 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.
Attention Control
NO INTERVENTIONAfter 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Carolina
Columbia, South Carolina, 29208, United States
Related Publications (2)
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.
PMID: 37665520BACKGROUNDMagwood 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.
PMID: 39310085RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gayenell S Magwood, PhD
University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 14, 2022
First Posted
May 11, 2022
Study Start
January 3, 2023
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share