COPD (Chronic Obstructive Pulmonary Disease)VALQASCINCT06652204
Validation of the French Version of the QASCI in Caregivers of Patients With COPD
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Caregiver, run by University Hospital, Brest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Caregiver
- What is being tested?
- questionnaire
- How many people
- 224 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Oct 2024to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Informal caregivers of patients with COPD
Who may be able to join
- 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.
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- NON-INCLUSION CRITERIA
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alan LE POUEZARD, physiotherapist contact
France2 sites, 2 recruiting
- Recruiting
Chu Brest
Brest, 29609
Marc Beaumont, PhD, +33 298626160, mbeaumont@ch-morlaix.fr
- Recruiting
Centre hospitalier de Morlaix
Morlaix, 29600
Marc Beaumont, PhD, +33 298626160, mbeaumont@ch-morlaix.fr
About this study
Official title: Validation of the French Version of the Informal Caregiver Burden Assessment Questionnaire (QASCI) in Caregivers of Patients With COPD (VALQASCI)
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.
Read more
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.
Read the detailed description
Beyond its respiratory component, COPD, being a systemic condition, leads to significant problems in various domains for patients. Dyspnea remains their main complaint, but these patients also experience impairments in physical capacity, nutritional status, and symptoms of anxiety and depression, which can limit their daily physical activity and reduce their quality of life, even their life expectancy.
As the disease progresses, patients become increasingly dependent on care, experiencing difficulties in performing activities of daily living (ADLs), and social isolation is often observed.
In this context, caregivers (usually a spouse or child) play a crucial role in supporting patients with ADLs, providing assistance with medical care and symptom management. Their presence is essential for facilitating and improving patients' adherence to COPD management behaviors, such as treatment compliance or increasing daily physical activity. Thus, their role in the healthcare system is fundamental, both as a link to medical teams and as support for the patient.
However, assuming the caregiver role can heavily impact the caregiver's physical, psychological, and social well-being. A survey in Spain reveals that many caregivers face health issues and experience reduced social, leisure, and professional activities due to their role. Additionally, they may feel helpless, anxious, depressed, and vulnerable to fatigue, incapacity, and/or burnout while trying to cope with the demands related to COPD. Other studies highlight the professional impact of caregiver status, with absences linked to this situation or decreased work effectiveness. This situation can be even more challenging for caregivers of patients with advanced COPD, who face higher risks of exacerbations, hospitalizations, and mortality compared to less severely affected patients.
It is therefore essential that healthcare professionals and paramedical staff who work with COPD patients and their caregivers have a tool to assess the burden on informal caregivers. To date, the only existing tool seems to be the QASCI questionnaire, drafted and validated in Portuguese by Hipólito et al. However, due to the language barrier, this tool cannot be used with French-speaking populations.
It is in this context that the present study finds its place, with the aim of establishing the validity and reliability of the French translation of the QASCI questionnaire.
- Being tested
- questionnaire
- Keywords
- validation of questionnaire, caregivers burnout, copd
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| caregivers of patients with COPD | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (1)
Assess the reliability of the translation of the long version of the QASCI questionnaire.
Responses to the QASCI questionnaire (32 items rated from 1 to 5 leading to an overall score and 7 subscores) at Day 0 and Day 15
Measured: baseline and at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start22 Oct 2024
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier des Pays de Morlaix
- Responsible party
- Principal investigator, BEAUMONT Marc, University Hospital, Brest
- Investigators
- Marc Beaumont, PhD, Principal investigator, Centre Hospitalier des Pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652204
- Sponsor's protocol ID
- 29BRC24.0115 - VALQASCI
- Acronym
- VALQASCI
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 36343503
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Informal Caregiver Burden Assessment Questionnaire (QASCI) in Caregivers of Patients With COPD (VALQASCI)
- ClinicalTrials.gov ID
- NCT06652204
- Acronym / sponsor ID
- VALQASCI / 29BRC24.0115 - VALQASCI
- Keywords
- validation of questionnaire, caregivers burnout, copd
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Centre Hospitalier des Pays de Morlaix
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Beyond its respiratory component, COPD, being a systemic condition, leads to significant problems in various domains for patients. Dyspnea remains their main complaint, but these patients also experience impairments in physical capacity, nutritional status, and symptoms of anxiety and depression, which can limit their daily physical activity and reduce their quality of life, even their life expectancy.
As the disease progresses, patients become increasingly dependent on care, experiencing difficulties in performing activities of daily living (ADLs), and social isolation is often observed.
In this context, caregivers (usually a spouse or child) play a crucial role in supporting patients with ADLs, providing assistance with medical care and symptom management. Their presence is essential for facilitating and improving patients' adherence to COPD management behaviors, such as treatment compliance or increasing daily physical activity. Thus, their role in the healthcare system is fundamental, both as a link to medical teams and as support for the patient.
However, assuming the caregiver role can heavily impact the caregiver's physical, psychological, and social well-being. A survey in Spain reveals that many caregivers face health issues and experience reduced social, leisure, and professional activities due to their role. Additionally, they may feel helpless, anxious, depressed, and vulnerable to fatigue, incapacity, and/or burnout while trying to cope with the demands related to COPD. Other studies highlight the professional impact of caregiver status, with absences linked to this situation or decreased work effectiveness. This situation can be even more challenging for caregivers of patients with advanced COPD, who face higher risks of exacerbations, hospitalizations, and mortality compared to less severely affected patients.
It is therefore essential that healthcare professionals and paramedical staff who work with COPD patients and their caregivers have a tool to assess the burden on informal caregivers. To date, the only existing tool seems to be the QASCI questionnaire, drafted and validated in Portuguese by Hipólito et al. However, due to the language barrier, this tool cannot be used with French-speaking populations.
It is in this context that the present study finds its place, with the aim of establishing the validity and reliability of the French translation of the QASCI questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caregivers of patients with COPD | – | Other: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Informal caregivers of patients with COPD
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireCaregivers 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). | Other | caregivers of patients with COPD |
Primary outcome
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.
Time frame: baseline
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).
1 secondary outcome
Assess the reliability of the translation of the long version of the QASCI questionnaire.
Time frame: baseline and at day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 36343503Hipolito 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan LE POUEZARD, physiotherapist contact
Marc Beaumont, PhD principal investigator
Centre Hospitalier des Pays de Morlaix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Caregiver, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc BEAUMONT, PhD (+33 298626160, mbeaumont@ch-morlaix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.