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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

Study 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.Check my eligibility
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.See study design
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
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in patient-reported outcomes measurement information system (PROMIS) Global Health Scale
Secondary outcome measures
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Change in Dyadic Efficacy
Change in Dyadic Illness Management Behaviors
+5 more

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.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,136 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,061 Total Patients Enrolled
University of South CarolinaLead Sponsor
211 Previous Clinical Trials
119,959 Total Patients Enrolled

Media Library

Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) Clinical Trial Eligibility Overview. Trial Name: NCT05370014 — N/A
Cardiovascular Disease Research Study Groups: iCINGS Fam Intervention, Attention Control
Cardiovascular Disease Clinical Trial 2023: Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) Highlights & Side Effects. Trial Name: NCT05370014 — N/A
Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370014 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for participants to enroll in this investigation?

"Correct. Per the information on clinicaltrials.gov, this trial is actively recruiting participants since its original posting date of March 1st 2023 and last edit on May 18th 2023. At present, 500 patients must be acquired from a single medical hub."

Answered by AI

What is the intake capacity of this medical experiment?

"Confirmed. Analysis of the clinicaltrials.gov data affirms that, since its inception on January 3rd 2023, this medical trial has been actively enrolling participants. 500 patients are currently being sought at a single location."

Answered by AI
~312 spots leftby Jun 2026