Community-based Nurse-Guided Intervention for COVID-19 Recovery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: Enrolled in related clinical trials
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
13467How 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.
35689Eligibility 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.
+5 more
Exclusion Criteria
You are already taking part in other similar research studies.
Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South CarolinaColumbia, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
University of South CarolinaLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Exploring the Impact of Storytelling for Hospitalized Patients Recovering from COVID-19. [2023]There are mental and physical deficits associated with COVID-19 infection, particularly among individuals requiring hospitalization. Storytelling is a relational intervention that has been used to help patients make sense of their illness experiences and to share their experiences with others, including other patients, families and healthcare providers. Relational interventions strive to create positive, healing stories versus negative ones. In one urban acute care hospital, an initiative called the Patient Stories Project (PSP) uses storytelling as a relational intervention to promote patient healing, including the development of healthier relationships among themselves, with families and with healthcare providers. This qualitative study employed a series of interview questions that were collaboratively developed with patient partners and COVID-19 survivors. The questions asked consenting COVID-19 survivors about why they chose to tell their stories and to flesh out more about their recovery process. Thematic analyses of six participant interviews resulted in the identification of key themes along a COVID-19 recovery pathway. Patients' stories revealed how survivors progress from being overwhelmed by their symptoms to making sense of what is happening to them, providing feedback to their care providers, feeling gratitude for care received, becoming aware of a new state of normal, regaining control of their lives, and ultimately discovering meaning and an important lesson behind their illness experience. Our study's findings suggest that the PSP storytelling approach holds potential as a relational intervention to support COVID-19 survivors along a recovery journey. This study also adds knowledge about survivors beyond the first few months of recovery.
Post-hospital recovery trajectories of family members of critically ill COVID-19 survivors: an international qualitative investigation. [2023]The immediate impact of coronavirus disease 2019 (COVID-19) visiting restrictions for family members has been well-documented. However, the longer-term trajectory, including mechanisms for support, is less well-known. To address this knowledge gap, we aimed to explore the post-hospital recovery trajectory of family members of patients hospitalised with a critical care COVID-19 admission. We also sought to understand any differences across international contexts.
Characteristics of Post-ICU and Post-COVID Recovery Clinics in 29 U.S. Health Systems. [2022]The multifaceted long-term impairments resulting from critical illness and COVID-19 require interdisciplinary management approaches in the recovery phase of illness. Operational insights into the structure and process of recovery clinics (RCs) from heterogeneous health systems are needed. This study describes the structure and process characteristics of existing and newly implemented ICU-RCs and COVID-RCs in a subset of large health systems in the United States.
Coping in times of disruption and deprivation-Experiences of family members during COVID-19 patients' critical illness: A qualitative study. [2023]To explore the experiences and needs of family members during the course of COVID-19 critical illness from onset to rehabilitation.
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]Phone-supported recovery of COVID-19 patients in home isolation could be an effective way of addressing COVID-19 in contexts with limited resources. The COVID-19 Care Companion Program (CCP) is one such intervention, designed to support patients and their caregivers in remote, evidence-based management of COVID-19 symptoms.
Developing the First Telenursing Service for COVID-19 Patients: The Experience of South Korea. [2021]This study aimed to examine the process of establishing a telenursing service for COVID-19 patients with mild or no symptoms admitted to a community treatment center (CTC). The process of establishing the service was reviewed, and the degree of satisfaction with the provided service was investigated based on the medical records the patients submitted at their discharge from the CTC. A total of 113 patients were admitted; the patients themselves entered the self-measured vital signs and symptoms of COVID-19 infection to the electronic questionnaires and mobile application. The nurses implemented remote nursing based on the patients' input data. The educational materials, including the video for self-measuring vital signs and the living guidelines, were prepared and arranged in advance. The telenursing protocol regarding the whole process from the patients' admission to their discharge was used and applied to five other CTCs. The non-contact counseling service's satisfaction and convenience scores were 4.65 points and 4.62 points, respectively, out of 5 points. The non-contact nursing counseling service played an important role in monitoring patients' medical conditions during the spread of COVID-19. This experience of establishing telenursing services to the CTC provides a clear direction to innovate healthcare services in future disasters.
Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019. [2021]Examine the safety and feasibility of a multimodal in-person or telehealth treatment program, administered in acute recovery phase for patients surviving critical coronavirus disease 2019.
Rapid Design and Implementation of Post-COVID-19 Clinics. [2022]Survivors of COVID-19 are a vulnerable population, with complex needs because of lingering symptoms and complications across multiple organ systems. Those who required hospitalization or intensive care are also at risk for post-hospital syndrome and post-ICU syndromes, with attendant cognitive, psychological, and physical impairments, and high levels of health care utilization. Effective ambulatory care for COVID-19 survivors requires coordination across multiple subspecialties, which can be burdensome if not well coordinated. With growing recognition of these needs, post-COVID-19 clinics are being created across the country. We describe the design and implementation of multidisciplinary post-COVID-19 clinics at two academic health systems, Johns Hopkins and the University of California-San Francisco. We highlight components of the model which should be replicated across sites, while acknowledging opportunities to tailor offerings to the local institutional context. Our goal is to provide a replicable framework for others to create these much-needed care delivery models for survivors of COVID-19.
Evaluation of a novel community-based COVID-19 'Test-to-Care' model for low-income populations. [2021]After a COVID-19 diagnosis, vulnerable populations face considerable logistical and financial challenges to isolate and quarantine. We developed and evaluated a novel, community-based approach ('Test-to-Care' Model) designed to address these barriers for socioeconomically vulnerable Latinx individuals with newly diagnosed COVID-19 and their households.