An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay (NBdelay)
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| ClinicalTrials.gov Identifier: NCT03820999 |
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Recruitment Status : Unknown
Verified January 2019 by Fredrikke Christie Knudtzen, Odense University Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 31, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lyme Neuroborreliosis | Other: Oral and written information on tick-bites and Lyme disease | Not Applicable |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Teaching arm
The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.
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Other: Oral and written information on tick-bites and Lyme disease
See under study arm descriptions |
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No Intervention: Passive arm
The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.
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- 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.
- 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).
- 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 |
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
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
| Contact: Fredrikke C Knudtzen, MD | 004529178083 | fredrikke.christie.knudtzen@rsyd.dk | |
| Contact: Sigurdur Skarphédinsson, MD, PhD | 004565414280 | s.skarphedinsson@rsyd.dk |
| Denmark | |
| Clinical Center for Emerging and Vectorborne Infections | |
| Odense, Funen, Denmark, 5000 | |
| Contact: Sigurdur Skarphedinsson, MD, PhD | |
| Principal Investigator: | Fredrikke C Knudtzen, MD | Department of Infectious Diseases, Odense University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fredrikke Christie Knudtzen, Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT03820999 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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treatment delay primary health care |
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Lyme Neuroborreliosis Central Nervous System Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Lyme Disease Gram-Negative Bacterial Infections |
Borrelia Infections Spirochaetales Infections Central Nervous System Infections Tick-Borne Diseases Vector Borne Diseases Central Nervous System Diseases Nervous System Diseases |