Validation of the French Version of the QASCI in Caregivers of Patients With COPD

NCT06652204 | Recruiting

• 1 other identifier: 29BRC24.0115 - VALQASCI
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to validate the French version of the QASCI questionnaire, initially written and validated in Portuguese language by Hipolito et al., to assess caregiving burden in chronic obstructive pulmonary disease (COPD). The realization of this validation is significant on several levels. First, since COPD is a systemic condition, it affects not only the lungs but also many other organs and systems in the body. It leads to various complications that go beyond respiratory symptoms, creating major challenges not only physically but also in terms of participation and involvement for patients and their caregivers. The lack of validated tools in French to specifically assess the quality of life of caregivers in this context represents a gap that this study seeks to fill. This study is also justified by the fact that, although the QASCI has been validated in other languages and contexts, it is essential to linguistically and culturally adapt this tool for the French-speaking population. Validation in French is crucial to ensure the fidelity of the results obtained and the validity of the conclusions drawn from this instrument for caregivers of patients with COPD in France. In summary, this study addresses a specific need by contributing to the prevention of pathologies among caregivers. It enhances early detection and support for caregivers of patients with COPD while paving the way for future research on this often-overlooked population.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Caregiver

Keywords

validation of questionnaire; caregivers burnout; copd

Outcome Measures

Primary Outcomes (1)

• Validation of the translation of the long version of the QASCI questionnaire (measuring caregiver burden) from Portuguese to French after the translation-back translation stage.

  Responses to the QASCI questionnaire (32 items rated from 1 to 5 leading to an overall score and 7 subscores) and comparison with responses to the ZBI (Zarit Burden Interview), HADS (Hospital Anxiety and Depression Scale), and WHOQOL-Bref (World Health Organization Quality of Life Instrument - Short Form).

  baseline

Secondary Outcomes (1)

• Assess the reliability of the translation of the long version of the QASCI questionnaire.

  baseline and at day 15

Study Arms (1)

caregivers of patients with COPD

Other: questionnaire

Interventions

questionnaire OTHER

Caregivers must reply to the French version of the QASCI questionnaire, the ZBI (Zarit Burden Interview) questionnaire, HADS (Hospital Anxiety and Depression Scale), and WHOQOL-Bref (World Health Organization Quality of Life Instrument - Short Form). After 15 days, they wil reply to the French version of the QASCI questionnaire (to asse the reliability).

caregivers of patients with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Informal caregivers of patients with COPD

You may qualify if:

• Being a caregiver of a relative with COPD (according to the GOLD criteria).
• Being 18 years old or older.
• The patient under the caregiver's care must be in stable condition (no exacerbations in the previous month).
• Being a family member of the patient or living with the patient.
• Being able to complete the French questionnaires.
• Non-opposition statement provided.
• Person under judicial protection (guardianship, curatorship, etc.)
• Refusal to participate
• The patient under the caregiver's care has experienced an exacerbation in the previous month
• The caregiver reports that the patient has cognitive impairments.

Sponsors & Collaborators

• University Hospital, Brest: lead
• Centre Hospitalier des Pays de Morlaix: collaborator

Study Sites (2)

Chu Brest

Brest, 29609, France

RECRUITING

Centre hospitalier de Morlaix

Morlaix, 29600, France

RECRUITING

Related Publications (1)

• Hipolito N, Martins S, Ruivo A, Flora S, Silva CG, Marques A, Brooks D, Cruz J. Construct validity and reliability of the Informal Caregiver Burden Assessment Questionnaire (QASCI) in caregivers of patients with COPD. Respir Med. 2022 Dec;205:107027. doi: 10.1016/j.rmed.2022.107027. Epub 2022 Oct 31.

  PMID: 36343503 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marc Beaumont, PhD

  Centre Hospitalier des Pays de Morlaix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc BEAUMONT, PhD

CONTACT

+33 298626160; mbeaumont@ch-morlaix.fr

Alan LE POUEZARD, physiotherapist

CONTACT

alanlepouezard240@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (2)