256 Participants Needed

COVID Prevention Counseling and Text Messaging for COVID-19

NC
Overseen ByNoe C Crespo, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: San Diego State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that COVID Prevention Counseling and Text Messaging for COVID-19 is an effective treatment?

The available research does not provide specific data on the effectiveness of COVID Prevention Counseling and Text Messaging for COVID-19. The articles focus on other programs and treatments, such as critical care pathways for different conditions and a Community Paramedic Program for transitioning patients from hospital to home. Without direct evidence from these studies, we cannot conclude the effectiveness of the COVID Prevention Program.12345

What safety data exists for the COVID Prevention Counseling and Text Messaging for COVID-19 treatment?

The provided research does not contain specific safety data for the COVID Prevention Counseling and Text Messaging for COVID-19 treatment or its other names like COVID Prevention Program (CPP). The research primarily focuses on COVID-19 vaccine safety and adverse events following immunization, not on counseling or text messaging interventions.678910

Is the COVID Prevention Program (CPP) a promising treatment for COVID-19?

Yes, the COVID Prevention Program (CPP) is promising because it uses phone calls and text messages to support people during the pandemic. This approach is effective, cost-efficient, and accessible, helping people manage COVID-19 symptoms and mental health challenges.811121314

How is the COVID Prevention Program (CPP) treatment different from other COVID-19 treatments?

The COVID Prevention Program (CPP) is unique because it combines counseling and text messaging to support COVID-19 prevention, focusing on remote and accessible communication methods to help people manage their health and well-being during the pandemic. This approach is different from traditional treatments that often involve medication or in-person care, as it leverages technology to provide support and information.811121314

What is the purpose of this trial?

This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.

Research Team

NC

Noe C Crespo, M.P.H, Ph.D.

Principal Investigator

San Diego State University Research Foundation

Eligibility Criteria

This trial is for adult patients over 18 years old who have tested positive for COVID-19 and are clients of a federally qualified health center. It's not suitable for those planning to move out of state within a year, individuals with cognitive impairments like schizophrenia or Down syndrome, or people without stable housing.

Inclusion Criteria

I am 18 or older and a patient at a federally qualified health center.
Test positive for COVID-19

Exclusion Criteria

Planning to move out of state in the next year
Living in a transitionary home or homeless.
I do not have a cognitive condition like schizophrenia or Down syndrome that would prevent me from following counseling.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week behavioral intervention with either standard-of-care or enhanced standard-of-care, including tailored phone/mobile counseling and weekly text messaging

6 weeks
Telemedicine follow-ups every 2-3 days, in-person follow-ups as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at multiple timepoints

24 months
Follow-up assessments at 1, 6, 12, and 24 months post-baseline

Treatment Details

Interventions

  • COVID Prevention Program (CPP)
Trial Overview The study tests a 6-week behavioral intervention called the COVID Prevention Program (CPP) against standard care. Participants will be randomly placed in two groups: one receiving usual clinical follow-up and another getting enhanced care with tailored text messages and virtual counseling from promotores/as.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Standard-of-CareExperimental Treatment1 Intervention
In addition to the aforementioned standard-of-care actions, index patients in the enhanced standard-of-care group will receive tailored phone/mobile counseling (motivational interviewing) focused on implementing strategies to prevent immediate household spread of COVID-19, followed by weekly text messaging for a total of 6 weeks.
Group II: Standard-of-CareActive Control1 Intervention
Patients who test positive will receive a call from the provider who conducted the test to notify them of the test result and provide standard-of-care counseling (e.g., health education, link them to resources). Index patients are entered into a COVID-19 patient registry in the Federally Qualified Health Center's electronic health record system (which also is linked to the clinic's COVID-19 dashboard) and monitored closely, with telemedicine follow-ups provided by skilled clinical staff every two-to-three days, and in-person follow-ups provided as needed.

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

Family Health Centers of San Diego

Collaborator

Trials
9
Recruited
15,000+

Findings from Research

Memorial Hospital implemented a program combining clinical pathways and disease management to reduce readmission rates and length of stay for chronic conditions, enhancing patient care continuity.
The program involves a coordinated effort between hospital care managers and outpatient case managers, ensuring smooth transitions from hospital to home care, which is expected to improve efficiency and offset revenue losses from reduced admissions.
Hospital program weds case, disease management.[2007]
The Community Paramedic Program (CPP) at Cape Fear Valley Medical Center involved fourth-year pharmacy students who conducted home visits for 124 patients, identifying 145 drug-related problems (DRP) and providing essential medication education, which highlights the program's effectiveness in improving patient care post-discharge.
Common issues included the continuation of medications that should have been stopped at discharge and medication safety concerns, indicating a need for better communication and management of medications during the transition from hospital to home.
Pharmacy student involvement in a transition of care program.Hertig, R., Ackerman, R., Zagar, B., et al.[2022]
The implementation of critical pathways (CP) in the management of STEMI patients significantly reduced the median door-to-balloon time from 85 to 64 minutes and increased the primary PCI rate within 90 minutes from 57% to 79%.
Despite these improvements in treatment efficiency, CP implementation did not affect symptom onset-to-door time, total ischemic time, or overall mortality rates at 30 days and 1 year, indicating that further strategies are necessary to enhance patient outcomes.
Effects of critical pathway on the management of patients with ST-elevation acute myocardial infarction in an emergency department.Ryu, DR., Choi, JW., Lee, BK., et al.[2015]

References

Hospital program weds case, disease management. [2007]
Pharmacy student involvement in a transition of care program. [2022]
Effects of critical pathway on the management of patients with ST-elevation acute myocardial infarction in an emergency department. [2015]
Effectiveness of critical care pathways for head and neck cancer surgery: A systematic review. [2018]
Clinical pathway care improves outcomes among patients hospitalized for community-acquired pneumonia. [2019]
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021. [2021]
A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee. [2023]
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]
[COVID-19 vaccine safety]. [2022]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. [2021]
Closing the Psychological Treatment Gap During the COVID-19 Pandemic With a Supportive Text Messaging Program: Protocol for Implementation and Evaluation. [2020]
Healthcare provider experiences of deploying a continuous remote patient monitoring pilot program during the COVID-19 pandemic: a structured qualitative analysis. [2023]
Leveraging community engaged research partnerships for crisis and emergency risk communication to vulnerable populations in the COVID-19 pandemic. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Telephonic Outreach to Engage Patients with Substance Use Disorder Post-Hospitalization During the COVID-19 Pandemic. [2023]
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