An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay (NBdelay)
Primary Purpose
Lyme Neuroborreliosis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Oral and written information on tick-bites and Lyme disease
Sponsored by
About this trial
This is an interventional treatment trial for Lyme Neuroborreliosis focused on measuring treatment delay, primary health care
Eligibility Criteria
Inclusion Criteria:
- Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of > 4.6/100.000
- Patients with a postal address on Funen and a positive Borrelia intrathecal antibody test (diagnostic for lyme neuroborreliosis) performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
- A Borrelia IgM/IgG serology ordered from Primary Health Care and performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
Exclusion Criteria:
- Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of < 4.7/100.000
Sites / Locations
- Clinical Center for Emerging and Vectorborne Infections
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teaching arm
Passive arm
Arm Description
The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.
The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.
Outcomes
Primary Outcome Measures
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis
Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.
Secondary Outcome Measures
Number of yearly referred Lyme patients
Number of yearly referred patients in the two study arms in the two years before the intervention (2017+2018) and after the intervention (2019+2020).
Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians
Number of Borrelia antibody tests in peripheral blood ordered by primary Health care physicians in the two study arms in the two years before (2017+2018) and after (2019 + 2020) the intervention.
Full Information
NCT ID
NCT03820999
First Posted
January 22, 2019
Last Updated
January 29, 2019
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03820999
Brief Title
An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay
Acronym
NBdelay
Official Title
An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the effect of written and oral information in a primary health care setting on 1) patients referred to specialised examination for Lyme neuroborreliosis, 2) delay from patient symptom debut to treatment for Lyme neuroborreliosis, and 3) number of Borrelia serology tests from primary health care.
Detailed Description
Lyme neuroborreliosis is among the most common neuroinfections in northern Europe. Residual symptoms after treatment are a frequent problem in Lyme neuroborreliosis, and an association between the delay from symptom debut to antibiotic treatment has been established. In a previous study on Funen Island, Denmark, the delay from day of symptom debut to treatment for Lyme neuroborreliosis patients was 24 days. This considerable treatment delay did not change in the 20 years study period.
In the Danish health system, the general practitioners are the first medical professionals to see the majority of patients. They can refer patients to the hospital for further examination if indicated. Many general practitioners use Borrelia burgdorferi antibodies (igM/IgG) as a screening tool when they suspect Lyme disease or see patients with uncharacteristic symptoms. This is unfortunate, as the rash Erythema Migrans, the most common Borreliosis manifestation in Europe, is a clinical diagnosis. Only around 50% of patients have positive antibodies at time of Erythema Migrans diagnosis. Lyme neuroborreliosis is diagnosed based on symptoms and the results from the cerebrospinal fluid, and cannot be diagnosed based on serology, which only delays the time to diagnoses and treatment. The Danish guidelines on Lyme borreliosis therefore discourage general practitioners from using Borrelia serology.
In the before mentioned study from Funen Island, several patients described multiple contacts to their general practitioners, where the symptoms of Lyme neuroborreliosis were not recognized. The cardinal symptom of radicular pain was associated with a longer delay than many of the less common symptoms of Lyme neuroborreliosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Neuroborreliosis
Keywords
treatment delay, primary health care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label interventional study where primary Health care Physicians in areas on Funen Island, Denmark, are included if they have their practice in an area with Lyme Neuroborreliosis incidens > 4.6/100.000
Masking
None (Open Label)
Masking Description
Open label study, due to the intervention (lectures) and the criteria for receiving the intervention (Lyme neuroborreliosis incidens > 4.6/100.000), the study cannot be blinded.
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teaching arm
Arm Type
Experimental
Arm Description
The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.
Arm Title
Passive arm
Arm Type
No Intervention
Arm Description
The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.
Intervention Type
Other
Intervention Name(s)
Oral and written information on tick-bites and Lyme disease
Intervention Description
See under study arm descriptions
Primary Outcome Measure Information:
Title
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis
Description
Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.
Time Frame
0-90 days
Secondary Outcome Measure Information:
Title
Number of yearly referred Lyme patients
Description
Number of yearly referred patients in the two study arms in the two years before the intervention (2017+2018) and after the intervention (2019+2020).
Time Frame
Up to 4 years (1460 days).
Title
Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians
Description
Number of Borrelia antibody tests in peripheral blood ordered by primary Health care physicians in the two study arms in the two years before (2017+2018) and after (2019 + 2020) the intervention.
Time Frame
Up to 4 years (1460 days).
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of > 4.6/100.000
Patients with a postal address on Funen and a positive Borrelia intrathecal antibody test (diagnostic for lyme neuroborreliosis) performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
A Borrelia IgM/IgG serology ordered from Primary Health Care and performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
Exclusion Criteria:
Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of < 4.7/100.000
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrikke C Knudtzen, MD
Phone
004529178083
Email
fredrikke.christie.knudtzen@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Sigurdur Skarphédinsson, MD, PhD
Phone
004565414280
Email
s.skarphedinsson@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrikke C Knudtzen, MD
Organizational Affiliation
Department of Infectious Diseases, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Center for Emerging and Vectorborne Infections
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigurdur Skarphedinsson, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to Denmark´s strict data-sharing Laws, data will not be shared after completion of study.
Citations:
PubMed Identifier
29048514
Citation
Knudtzen FC, Andersen NS, Jensen TG, Skarphedinsson S. Characteristics and Clinical Outcome of Lyme Neuroborreliosis in a High Endemic Area, 1995-2014: A Retrospective Cohort Study in Denmark. Clin Infect Dis. 2017 Oct 16;65(9):1489-1495. doi: 10.1093/cid/cix568.
Results Reference
result
PubMed Identifier
35323885
Citation
Knudtzen FC, Jensen TG, Andersen NS, Johansen IS, Hovius JW, Skarphedinsson S. An intervention in general practice to improve the management of Lyme borreliosis in Denmark. Eur J Public Health. 2022 Jun 1;32(3):436-442. doi: 10.1093/eurpub/ckac013.
Results Reference
derived
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An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay
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