Clincosm LogoSign in Get a demo

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

Sponsor
Dr. Daniel Cameron & Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT05312619
Collaborator
(none)
2,000
Enrollment
1
Location
28
Anticipated Duration (Months)
71.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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

  1. in those who have taken the COVID-19 vaccine? Do they differ?

  1. 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?

  2. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?

  3. 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 Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Burden of Lyme Disease (BOLD) in a Pandemic
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Jul 7, 2023
Anticipated Study Completion Date :
Nov 7, 2023

Outcome Measures

Primary Outcome Measures

  1. Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30) [7/21 to 7/23]

    Cross sectional

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  • ≥12 years old

  • a self-report of having been diagnosed with Lyme disease.

Exclusion Criteria:
  • There are no exclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daniel Cameron Mount Kisco New York United States 10549

Sponsors and Collaborators

  • Dr. Daniel Cameron & Associates

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Cameron, Chief Investigator, Dr. Daniel Cameron & Associates
ClinicalTrials.gov Identifier:
NCT05312619
Other Study ID Numbers:
  • 20212917
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Lyme Disease

Study Results

No Results Posted as of Apr 5, 2022