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Community-based Nurse-Guided Intervention for COVID-19 Recovery

N/A

Recruiting

Led By Gayenell S Magwood, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A history of a COVID-19-associated hospitalization since March 11th 2020

≥ 18 years and above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an intervention to help African Americans with chronic illnesses and their caregivers better cope with the health effects of COVID-19.

Who is the study for?

This trial is for African American adults over 18 living in medically underserved areas of South Carolina, with a history of COVID-19 hospitalization and chronic conditions like diabetes, hypertension, or heart disease. They must be caring for someone with similar health issues within a close proximity but cannot be paid caregivers.

What is being tested?

The study examines the iCINGS FAM program's effectiveness in improving health outcomes for African Americans who have had COVID-19 and suffer from chronic illnesses, along with their informal carepartners.

What are the potential side effects?

Since this intervention involves community-based support and nursing guidance rather than medication, there are no typical drug side effects. However, participants may experience stress or emotional discomfort during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized due to COVID-19 after March 11th, 2020.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 7 months. minimum score 10 to maximum score 50. higher scores mean better. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale

Secondary study objectives

Change in Center for Epidemiologic Studies Depression Scale (CES-D)

Change in Dyadic Efficacy

Change in Dyadic Illness Management Behaviors

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iCINGS Fam InterventionExperimental Treatment1 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.

Group II: Attention ControlActive Control1 Intervention

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.

0 / 2Eligibility criteria met