NCT06327802

Brief Summary

The main objective of the study is to determine the impact of cystic fibrosis affecting a child on the parents' quality of life, their possible anxiety and depressive symptoms, their general fatigue and the feeling of burden in these caregivers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

March 17, 2024

Last Update Submit

April 30, 2024

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosiscaregiversburden

Outcome Measures

Primary Outcomes (1)

  • Zarit Burden Interview

    The Zarit Burden Interview, a popular caregiver self-report measure used, contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).

    1 year

Interventions

QuestionnaireOTHER

Participants will have to answer the socio-demographic questions (Age, weight, height, FEV1, FVC) and the Beck, Zarit, HAD, FAS CARERQOL-7D questionnaires

Eligibility Criteria

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

The subjects recruited are parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.

You may qualify if:

  • parents (father, mother, dyads (father+mother) of children suffering from cystic fibrosis) who agree to answer the various questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSLA GDD

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

March 17, 2024

First Posted

March 25, 2024

Study Start

April 1, 2024

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)