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

Trial Summary

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 data supports the effectiveness of the treatment Integrating Community-based Intervention Under Nurse Guidance with Families (iCINGS FAM) for COVID-19 recovery?

The COVID-19 Care Companion Program in Punjab, India, showed that phone-supported recovery can effectively help COVID-19 patients manage symptoms at home, suggesting that community-based interventions can be beneficial. Additionally, storytelling interventions have been found to aid in the mental and emotional recovery of COVID-19 patients, indicating that relational support can play a role in recovery. ^{1 2 3 4 5}

Is the Community-based Nurse-Guided Intervention for COVID-19 Recovery safe for humans?

The safety of a multimodal treatment program for COVID-19 recovery, which may include nurse-guided interventions, has been examined and found to be safe and feasible for patients recovering from critical COVID-19. ^{1 3 4 6 7}

How is the iCINGS FAM treatment for COVID-19 recovery different from other treatments?

The iCINGS FAM treatment is unique because it is a community-based intervention guided by nurses, focusing on integrating family support in the recovery process. This approach is different from traditional treatments as it emphasizes remote, nurse-led care and family involvement, which can be particularly beneficial for patients recovering at home or in community settings. ^{3 5 6 8 9}

What is the purpose of this trial?

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.

Research Team

Gayenell S Magwood, PhD

Principal Investigator

University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Impact of Storytelling for Hospitalized Patients Recovering from COVID-19. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Post-hospital recovery trajectories of family members of critically ill COVID-19 survivors: an international qualitative investigation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Post-ICU and Post-COVID Recovery Clinics in 29 U.S. Health Systems. [2022]

4. United States 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. [2023]

5. India 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Developing the First Telenursing Service for COVID-19 Patients: The Experience of South Korea. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Rapid Design and Implementation of Post-COVID-19 Clinics. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel community-based COVID-19 'Test-to-Care' model for low-income populations. [2021]