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

Overseen By Program Coordinator, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Enrolled in related clinical trials

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist African American adults who have experienced severe COVID-19 and manage chronic health issues such as diabetes, high blood pressure, heart problems, kidney disease, or a history of stroke. The trial evaluates a nurse-guided community program, Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM), to see if it can enhance recovery and overall health for participants and their care partners. One group will participate in a 14-week telehealth program led by nurses and community health workers, while another group will receive general health advice via phone calls. Ideal participants are those who have been hospitalized or visited an ER for COVID-19 and reside in medically underserved or rural areas of South Carolina. As an unphased trial, this study provides a unique opportunity to contribute to community health improvements and receive personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for participants?

Research has shown that the iCINGS FAM program, led by community nurses, has been used in similar situations without major safety issues. In a related study, the COVID-19 Care Companion Program achieved good results, including a 48% reduction in hospital visits, suggesting the program's likely safety.

The iCINGS FAM program involves community health workers and nurses assisting families through a telehealth program over several weeks. Although specific safety data for this exact program is unavailable, community and nurse-led healthcare programs are generally safe. These programs focus on teaching and support rather than medical procedures, which typically carry fewer risks.

Given the program's nature, it is likely safe for participants. However, discussing any concerns with the trial team or a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community-based Nurse-Guided Intervention for COVID-19 Recovery because it takes a fresh approach by integrating family support with healthcare guidance through telehealth. Unlike standard treatments that often focus solely on individual medical care, this method emphasizes the role of family and community in recovery, coordinated by nurses and community health workers. This approach could provide more holistic and personalized care, potentially leading to better outcomes, especially for those who benefit from strong support systems. Additionally, the use of telehealth makes it accessible and convenient for participants who may have limited mobility or live in remote areas.

What evidence suggests that the iCINGS FAM intervention is effective for COVID-19 recovery in African American adults with chronic health conditions?

Research has shown that community-based programs led by nurses can significantly reduce hospital visits due to COVID-19. One past study demonstrated a 48% reduction in hospital visits with a similar program. In this trial, participants in the iCINGS FAM Intervention arm will undergo a 14-week, nurse-coordinated, Community Health Worker-supported telehealth intervention. This approach includes phone training for patients and their caregivers, enabling better health management at home. The program also aims to enhance COVID-19 testing and control, facilitating preventive measures. Community-focused strategies are crucial because they address local needs and priorities, increasing their effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Gayenell S Magwood, PhD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either male or female.

I have been diagnosed with diabetes, high blood pressure, heart disease, kidney disease, or had a stroke over 3 months ago.

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

Exclusion Criteria

You are already taking part in other similar research studies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants before randomization into intervention or control groups

1 week

Intervention

iCINGS FAM intervention with two planning sessions over 2 weeks followed by eight topic-guided sessions over 12 weeks

14 weeks

Weekly sessions for the first 4 weeks, then bi-weekly

Attention Control

Monthly scripted phone calls focused on general health risks and health promotion

3 months

3 phone calls (7-10 min each)

Follow-up

Participants are monitored for changes in health outcomes and behaviors at months 4 and 7

3 months

Follow-up assessments at month 4 and month 7

What Are the Treatments Tested in This Trial?

Interventions

• Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM)

Trial Overview 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.

How Is the Trial Designed?

Group I: iCINGS Fam Intervention Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The COVID-19 Care Companion Program (CCP), a phone-based training intervention for patients and caregivers, significantly reduced hospitalizations by 48% within 21 days compared to standard care.

While the CCP did not show a significant effect on mortality rates, its ability to lower hospitalization rates suggests it could help alleviate pressure on healthcare systems during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can training over phone calls help improve outcomes for COVID-19 positive patients under home isolation? An analysis of the COVID-19 Care Companion Program in Punjab, India. Murthy, S., Chandrasekar, A., Yan, SD., et al.[2023]

The Patient Stories Project (PSP) uses storytelling as a relational intervention to help COVID-19 survivors make sense of their illness and promote healing, revealing a pathway from feeling overwhelmed to regaining control and finding meaning in their experiences.

Qualitative interviews with six COVID-19 survivors identified key themes in their recovery, suggesting that storytelling can foster healthier relationships with themselves, families, and healthcare providers, and may support long-term recovery beyond the initial months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Impact of Storytelling for Hospitalized Patients Recovering from COVID-19. Gurney, L., Chung, V., MacPhee, M., et al.[2023]

Family members of critically ill COVID-19 patients experienced significant emotional and physical burdens, often facing their own health issues while being unable to visit or communicate effectively with their loved ones in the hospital.

After patients were discharged, family members felt a sudden shift in responsibility, highlighting the need for better support and communication throughout the patient's critical illness and recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping in times of disruption and deprivation-Experiences of family members during COVID-19 patients' critical illness: A qualitative study. Berntzen, H., Lind, R., Alfheim, H., et al.[2023]

COVID-19 survivors, especially those who were hospitalized or in intensive care, face complex health challenges that require coordinated care across multiple medical specialties due to lingering symptoms and complications.

The establishment of multidisciplinary post-COVID-19 clinics at institutions like Johns Hopkins and UC-San Francisco provides a replicable framework for effectively addressing the diverse needs of these patients, ensuring better management of their health post-recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Design and Implementation of Post-COVID-19 Clinics. Santhosh, L., Block, B., Kim, SY., et al.[2022]

The Test-to-Care Model effectively supported 83 newly diagnosed COVID-19 patients, primarily Latinx individuals, by providing essential resources and community health worker support, with 65% receiving ongoing assistance throughout their isolation period.

Participants reported high satisfaction with the intervention, which increased their trust in the healthcare system, leading to more individuals seeking additional support and services, while no unintended harms were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel community-based COVID-19 'Test-to-Care' model for low-income populations. Kerkhoff, AD., Sachdev, D., Mizany, S., et al.[2021]

A multimodal treatment program combining interdisciplinary care and physical rehabilitation is safe and feasible for patients recovering from acute respiratory failure due to COVID-19, with no significant differences in safety events between in-person and telehealth groups.

Patients showed significant improvement in physical function, as evidenced by a 101-meter increase in the six-minute walk distance after the program, indicating effective rehabilitation regardless of the delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019. Mayer, KP., Parry, SM., Kalema, AG., et al.[2021]

Family members of patients who survived critical care COVID-19 admissions face significant long-term challenges, including changes in relationships and increased caregiver burden, as revealed through interviews with 19 participants from Spain and the UK.

The study highlights the importance of tailored support mechanisms, such as peer support networks, to address the ongoing needs of these family members, with notable differences in support systems based on cultural contexts, particularly the role of religion in Spain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-hospital recovery trajectories of family members of critically ill COVID-19 survivors: an international qualitative investigation. McPeake, J., Castro, P., Kentish-Barnes, N., et al.[2023]

A survey of 39 recovery clinics (RCs) across 29 health systems in the U.S. revealed that ICU-RCs utilize a more comprehensive approach to assess recovery, using validated scales for psychological, physical, and cognitive recovery more frequently than COVID-RCs.

The study highlights the variability in funding and operational structures of RCs, with many relying on clinical billing and volunteer support, indicating a need for standardized practices to improve recovery outcomes for patients after critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Post-ICU and Post-COVID Recovery Clinics in 29 U.S. Health Systems. Danesh, V., Boehm, LM., Eaton, TL., et al.[2022]

A telenursing service was successfully established for 113 COVID-19 patients with mild or no symptoms, allowing them to self-report vital signs and symptoms through electronic questionnaires and a mobile app, which nurses used to provide remote care.

Patients reported high satisfaction with the telenursing service, scoring 4.65 for satisfaction and 4.62 for convenience out of 5, highlighting its effectiveness in monitoring health during the pandemic and suggesting a model for future healthcare innovations in emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the First Telenursing Service for COVID-19 Patients: The Experience of South Korea. Heo, H., Lee, K., Jung, E., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-renal-insufficiency-chronic-7-2022-88706

Community-based Nurse-Guided Intervention for COVID ... The COVID-19 Care Companion Program (CCP), a phone-based training intervention for patients and caregivers, significantly reduced hospitalizations by 48% within ...

2. scholarcommons.sc.edu scholarcommons.sc.edu/cgi/viewcontent.cgi?article=1055&context=nurs_facpub

Exploring Barriers to Effective COVID-19 Risk Mitigation ... 8 This formative study was designed to elicit stakeholder concerns, priorities, and preferences to tailor the iCINGS FAM intervention to COVID- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11444061/

Integrated Community-Based Care for Dependent Older ... This study investigated the integration of community participatory systems in older care to address potential COVID-19 recurrence and develop policy proposals.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8803391/

Patients, Families, and Communities COVID-19 Impact ... The report concluded that community-driven solutions are necessary, as communities are in a unique position to drive priorities and actions tailored to their ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04832919

A Nurse-Community Health Worker-Family Partnership ... The study hypothesis is that the Nurse-CHW-Family Partnership intervention will improve household-level COVID-19 testing uptake, adoption of COVID control ...

6. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-26-2021/number-2-may-2021/the-impact-of-covid-19-on-the-nursing-workforce/

The Impact of COVID-19 on the Nursing Workforce: A National ... The purpose of this article is to provide a comprehensive overview of the issues that the COVID-19 pandemic amplified and created in the nursing workforce ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2093791123000719

Surviving Covid-19 Diagnosis Among Registered Nurses To mitigate the spread of Covid-19, nurses infected with the virus were required to isolate themselves from their families and community.