Clinical trial NCT04380870: Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19
Official title: Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Keywords: COVID-19 symptoms
Chinese Herbal Medicine
Cough
Shortness of Breath
Fatigue
Epidemic
Infectious Disease
Dyspnea
Diarrhea
Myalgia
Nausea
Fever
Pneumonia
Lead sponsor: Center for Integrated Care
Sponsor class: OTHER
Collaborators: name: University of Utah
name: University of California, San Francisco
First posted: 2020-05-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 114
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample.

Brief summary: The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.

Detailed description: The purpose of this study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19 infection who participate in Chinese herbal medicine (CHM) telehealth visits and take CHM. CHM includes over 400 medicinal substances and CHM formulas are individualized at each visit according to the patient's presentation. CHM has been used to treat cough, shortness of breath, and fatigue and mechanisms of action have been investigated for SARS and H1N1 influenza prevention and treatment by anti-inflammatory effects and antiviral activity. Yet, there is a gap in our understanding of the clinical application of CHM in a community sample of individuals experiencing symptoms that may be related to COVID-19. The investigators have no pragmatic clinic data about the use of CHM for coronaviruses.

Safe and effective treatment of symptoms associated with COVID-19 is a top international priority and research is needed to better understand if CHM is a safe intervention to treat symptoms. Further, dissemination of trustworthy CHM treatment approaches for this complex and emergent condition is needed within the CHM and scientific communities.

Aim 1: Conduct quantitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.

Case series will be reported bi-weekly to CHM clinicians via the SIEAM website including exposure, comorbidities, symptom change, concurrent medications, CHM prescriptions, adverse events and usability. Data will be analyzed at the study conclusion for presentation to the scientific community.

Aim 2: Conduct qualitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.

Chart notes reflecting clinicians' clinical reasoning will be content analyzed and posted bi-weekly on the SIEAM website. This will provide timely information for the CHM clinical community from highly experienced clinicians. Data will be analyzed at the study conclusion for presentation to the scientific community.

Eligibility criteria: Inclusion Criteria:

* Eighteen year of age.
* Experienced one or more of the following symptoms in the last 28 days: cough, fever, shortness of breath, diarrhea, nausea, or abdominal pain OR am at high risk of exposure.
* Have a Primary Care Provider.

Exclusion Criteria:

* Breastfeeding, pregnant, or expect that I might be pregnant.
* Ineligible to receive a telehealth consult for any reason.
* Unable to communicate in English verbally, and in writing.
* Have an open legal case about my health.
* Taking anticoagulants, immunosuppressants, antiseizure medications, antipsychotic medications or am in active cancer treatment
* Taking medications with some risk of interaction with the herbal medicine. This will be determined at the time of the herbal consult by the clinic team.
* Discretion of the practitioner or screener.

Primary outcomes:
measure: Patient reported main complaint
timeFrame: 24 hours
measure: Patient reported main complaint
timeFrame: 48 hours
measure: Patient reported main complaint
timeFrame: 3 months
measure: Patient reported main complaint
timeFrame: 12 months
Secondary outcomes:
measure: Conduct qualitative analyses of data
timeFrame: 24 hours
measure: Conduct qualitative analyses of data
timeFrame: 48 hours
measure: Conduct qualitative analyses of data
timeFrame: 3 months
measure: Conduct qualitative analyses of data
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Intstitute of East Asian Medicine
state: Washington
Study officials:
affiliation: University of Utah
name: Lisa Taylor-Swanson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconness Medical Center, Harvard Medical School
name: Lisa Conboy, DSc
role: PRINCIPAL_INVESTIGATOR
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