The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey

The Burden of Lyme Disease (BOLD) in a Pandemic

A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; COVID-19 Vaccine; Lyme Disease
• Intervention / Treatment: Other: Cross sectional survey

Detailed Description

Primary research question:

1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?

Secondary research questions:

1. Will the BOLD be worse for individuals who have been ill with COVID-19?
2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Daniel Cameron, MD, MPH; Phone Number: 9143251471; Email: dcameron@danielcameronmd.com

Study Locations

• United States
  • New York
    • Mount Kisco, New York, United States, 10549
      • Recruiting
      • Daniel Cameron
      • Contact: Daniel Cameron, MD, MPH; Phone Number: 914-325-1471; Email: dcameron@danielcameronmd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not.

Description

Inclusion Criteria:

• ≥12 years old
• a self-report of having been diagnosed with Lyme disease.

Exclusion Criteria:

• There are no exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)	Cross sectional	7/21 to 7/23

Collaborators and Investigators

• Sponsor: Dr. Daniel Cameron & Associates

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2021
• Primary Completion (ANTICIPATED): July 7, 2023
• Study Completion (ANTICIPATED): November 7, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; COVID-19; Lyme Disease
• Other Study ID Numbers: 20212917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No