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An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay (NBdelay)

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ClinicalTrials.gov Identifier: NCT03820999
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Fredrikke Christie Knudtzen, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Lyme Neuroborreliosis Other: Oral and written information on tick-bites and Lyme disease Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
Experimental: Teaching arm
The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.
Other: Oral and written information on tick-bites and Lyme disease
See under study arm descriptions

No Intervention: Passive arm
The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.



Primary Outcome Measures :
  1. Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis [ Time Frame: 0-90 days ]
    Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.


Secondary Outcome Measures :
  1. Number of yearly referred Lyme patients [ Time Frame: Up to 4 years (1460 days). ]
    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).

  2. Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians [ Time Frame: Up to 4 years (1460 days). ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820999


Contacts
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Contact: Fredrikke C Knudtzen, MD 004529178083 fredrikke.christie.knudtzen@rsyd.dk
Contact: Sigurdur Skarphédinsson, MD, PhD 004565414280 s.skarphedinsson@rsyd.dk

Locations
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Denmark
Clinical Center for Emerging and Vectorborne Infections Not yet recruiting
Odense, Funen, Denmark, 5000
Contact: Sigurdur Skarphedinsson, MD, PhD         
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Fredrikke C Knudtzen, MD Department of Infectious Diseases, Odense University Hospital

Publications of Results:
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Responsible Party: Fredrikke Christie Knudtzen, Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03820999     History of Changes
Other Study ID Numbers: FCKPhDProject4
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to Denmark´s strict data-sharing Laws, data will not be shared after completion of study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fredrikke Christie Knudtzen, Odense University Hospital:
treatment delay
primary health care

Additional relevant MeSH terms:
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Lyme Neuroborreliosis
Lyme Disease
Central Nervous System Bacterial Infections
Bacterial Infections
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases