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

NCT03820999 | Unknown DMC

• 1 other identifier: FCKPhDProject4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Neuroborreliosis

Keywords

treatment delay; primary health care

Outcome Measures

Primary Outcomes (1)

• 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.

  0-90 days

Secondary Outcomes (2)

• Number of yearly referred Lyme patients

  Up to 4 years (1460 days).

• Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians

  Up to 4 years (1460 days).

Study Arms (2)

Teaching arm

EXPERIMENTAL

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

Passive arm

NO INTERVENTION

The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.

Interventions

Oral and written information on tick-bites and Lyme disease OTHER

See under study arm descriptions

Teaching arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of \< 4.7/100.000

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Clinical Center for Emerging and Vectorborne Infections

Odense, Funen, 5000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29048514 RESULT

• 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.

  PMID: 35323885 DERIVED

MeSH Terms

Conditions

Lyme Neuroborreliosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Fredrikke C Knudtzen, MD

  Department of Infectious Diseases, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrikke C Knudtzen, MD

CONTACT

004529178083; fredrikke.christie.knudtzen@rsyd.dk

Sigurdur Skarphédinsson, MD, PhD

CONTACT

004565414280; s.skarphedinsson@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)