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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03820999
Acronym
NBdelay
Enrollment
60
Registered
2019-01-29
Start date
2019-02-28
Completion date
2021-04-01
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lyme Neuroborreliosis

Keywords

treatment delay, primary health care

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.

Interventions

OTHEROral and written information on tick-bites and Lyme disease

See under study arm descriptions

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis0-90 daysNumber of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.

Secondary

MeasureTime frameDescription
Number of yearly referred Lyme patientsUp 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).
Number of Borrelia antibody tests in peripheral blood ordered by primary care physiciansUp 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.

Countries

Denmark

Contacts

Primary ContactFredrikke C Knudtzen, MD
fredrikke.christie.knudtzen@rsyd.dk004529178083
Backup ContactSigurdur Skarphédinsson, MD, PhD
s.skarphedinsson@rsyd.dk004565414280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026