NCT04625829

Brief Summary

Patients and parents of patients will be asked to answer a questionnaire on paper or online, by the CRCMs and through communication campaigns distributed by the association Vaincre La Mucoviscidose (VLM). This questionnaire includes about fifty items that will take 5 to 12 minutes to complete. The study aims to interview 250 patients / parents of patients, users and non-users of essential oils. Thirty patients or volunteer parents will then meet with a health anthropologist for qualitative interviews to document very precisely the modalities of use of essential oils: which ones, at what dose, advised by whom, the dedicated budget. Relationships with CRCM doctors, the effects felt, the side effects will also be explored. The global data of the two phases will be integrated and put into perspective with the scientific data currently available on essential oils.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 5, 2020

Last Update Submit

November 6, 2020

Conditions

Mucoviscidosis

Outcome Measures

Primary Outcomes (1)

  • Frequency of use of the different EO by the patients who answered the questionnaire

    Frequency of use of the different EO by the patients who answered the questionnaire

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cystic fibrosis patient

You may qualify if:

  • Cystic fibrosis patient or parent of a child with cystic fibrosis

You may not qualify if:

  • patient who refused

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

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

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share