NCT05678478

Brief Summary

the study is offered to adolescents aged 12 to 17 and their families suspected of or suffering from Lyme barilliosis. During inclusion, three interviews will be carried out for each family. This choice of the number of interviews per family seems the most appropriate to have a plurality of answers to the questions asked. Thus, these will have a duration of 30 min to 1 hour and will be carried out by an anthropologist. The first interview will be with the teenager. The second interview will then concern the parent(s). Finally, the last appointment will be with the teenager and his parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

December 23, 2022

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Story of the teenager and one of his parents or both parents

    analysis and identification of perceptions, representations and experiences of adolescents and their parents on Lyme borreliosis and ticks

    Baseline

Interventions

semi-structured interview on the experience of adolescents and their parents on Lyme borreliosis and the tick. The interviews will be semi-directed in physical presence. Three interviews will be conducted. The minor will be questioned first, then the parent(s). And finally, the whole family in one interview. All interviews will be audio recorded with parallel note taking in order to best transcribe the visual expressions. The interviews will be transcribed in writing and pseudonymised.

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

These are patients aged 12 to 17 years maximum and their parents come for a suspicion of adolescent Lyme borreliosis.

You may qualify if:

  • Be at least 12 years old and maximum 17 years old.
  • Be accompanied by a holder of parental authority
  • Live in metropolitan France.
  • Suspect or have Lyme borreliosis
  • Non-objection for participation in the protocol

You may not qualify if:

  • Refusal of participation of a holder of parental authority and of the adolescent
  • Non-mastery of oral French by the teenager or his parents
  • Protected persons (patients under guardianship or curatorship, pregnant or nursing women, persons deprived of liberty, person unable to express their non-objection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal Villeneuve Saint Georges

Crosne, 91560, France

Location

Hôpital Armand Trousseau AP-HP

Paris, 75012, France

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 10, 2023

Study Start

February 1, 2023

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations