Idiopathic Pulmonary FibrosisHELP-IPFNCT04031690
Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients
An observational study of Idiopathic Pulmonary Fibrosis and Patient-caregiver Dyads, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Patient-caregiver Dyads
- What is being tested?
- Caregiver Quality of Life Questionnaires and Patient Quality of Life Questionnaires
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2019to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Consultation at the Reference or Competence Centre for Rare Adult Lung Diseases
Who may be able to join
- Patient inclusion criteria:
- Patient rescruited from prevalent cases and incidents of patients with IPF according to the diagnostic criteria of the 2011 ATS/ERS/JRS/ALAT recommendations, for which a follow-up is planned or is in progress
- Patient with a validated IPF diagnosis in multidisciplinary discussion in a Competence or Reference Centre. Regardless of the stage of the disease.
- Patient who has not opposed their enrollment in the study
- Adult patient
- Patient able to be assessed every 6 months by principal investigator
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- A patient who can designate a non-professional primary caregiver regardless of kinship, age or involvement with the patient (the primary caregiver is defined as the person who works most frequently with the patient). Only one caregiver is retained per patient.
- Patient with no memory or comprehension problems and able to read and write French
- Caregiver Inclusion Criteria:
- Caregiver designated by the patient as his or her primary caregiver
- Caregiver who has not opposed their participation in the study
- Adult caregiver
- Caregiver with no comprehension problems and able to read and write in French
- Caregiver with no memory problems
Who cannot join
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person with a legal guardian
- Adult unable to consent
- Patient non-inclusion criteria:
- Psychiatric, cognitive or neurological disorders making assessment impossible
- Patient suffering from another medical condition considered severe by the investigator and which may interfere with the consequences of IVF (for example, active cancers, motor disability of neurological origin, osteo-articular diseases inducing dependence...)
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- Not likely to complete a self-administered questionnaire
- Caregiver non-inclusion criteria:
- Psychiatric, cognitive or neurological disorders making assessment impossible
- Not likely to complete a self-administered questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence.
The factors involved in the alteration of QoL in these patients are the physical symptoms related to fibrosis (dyspnea, cough, fatigue) and psychological symptoms (anxiety and depression) as well as social, relational and financial factors, the experience of the disease and disability, the time required for diagnosis, the information received, and the initiation of a treatment such as oxygen therapy.
Read more
Caregivers primarily in chronic diseases (so-called natural or informal caregivers) provide partial or total assistance to a dependent person for activities of daily living for care, social support and maintenance of autonomy, administrative procedures, psychological support, communication, domestic activities or even financial assistance, often despite their own exhaustion and health issues.
Recent studies on the QoL of patient-caregiver dyads in IPF through semi-structured interviews highlight the role of previously identified factors in caregivers as well.
Investigators want to confirm the data obtained in a large population of patients and their caregivers in order to evaluate the QoL of caregivers and confirm the impact of its various factors on it in order to suggest ways to improve the lives of both the caregiver and the patient.
The hypothesis of investigators' work is that the QoL of caregivers of patients with IPF is altered, particularly by the patient's functional symptoms (cough, dyspnea, fatigue, anxiety and depression), the arrival of oxygen therapy in the home and the caregiver's social isolation.
Investigators believe that there are links and interactions between the caregiver's and patient's quality of life and therefore have an impact on the patient's care.
- Being tested
- Caregiver Quality of Life Questionnaires, Patient Quality of Life Questionnaires
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Quality of Life QuestionnairesOther
Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score
Patient Quality of Life QuestionnairesOther
Quality of life measurement at D0, M6 and M12 via the SF-36
| Study group | Role | What they receive |
|---|---|---|
| patient-caregiver dyads | Not described Receives: Other: Caregiver Quality of Life Questionnaires; Other: Patient Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The generic quality of life score SF-36 to measure caregivers' quality of life
Measurement of caregivers' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions of the component
Measured: Through study completion, an average of 12 months
The specific quality score CarGOQoL to measure caregivers' quality of life
Measurement of caregivers' quality of life via the specific quality score CarGOQoL in each of the 10 dimensions of the component
Measured: Through study completion, an average of 12 months
Secondary outcomes (2)
"subjective burden" of caregivers
Measurement of the "subjective burden" of caregivers via the one-dimensional Zarit score
Measured: Through study completion, an average of 12 months
Patients' Quality of life
Measurement of patients' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start14 Oct 2019
- Primary completion28 Sep 2020
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031690
- Sponsor's protocol ID
- BELTRAMO FRSR 2018
- Acronym
- HELP-IPF
- Status last verified
- Apr 2022
- First submitted
- 22 Jul 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04031690
- Acronym / sponsor ID
- HELP-IPF / BELTRAMO FRSR 2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 24 Jul 2019 (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.
Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence.
The factors involved in the alteration of QoL in these patients are the physical symptoms related to fibrosis (dyspnea, cough, fatigue) and psychological symptoms (anxiety and depression) as well as social, relational and financial factors, the experience of the disease and disability, the time required for diagnosis, the information received, and the initiation of a treatment such as oxygen therapy.
Caregivers primarily in chronic diseases (so-called natural or informal caregivers) provide partial or total assistance to a dependent person for activities of daily living for care, social support and maintenance of autonomy, administrative procedures, psychological support, communication, domestic activities or even financial assistance, often despite their own exhaustion and health issues.
Recent studies on the QoL of patient-caregiver dyads in IPF through semi-structured interviews highlight the role of previously identified factors in caregivers as well.
Investigators want to confirm the data obtained in a large population of patients and their caregivers in order to evaluate the QoL of caregivers and confirm the impact of its various factors on it in order to suggest ways to improve the lives of both the caregiver and the patient.
The hypothesis of investigators' work is that the QoL of caregivers of patients with IPF is altered, particularly by the patient's functional symptoms (cough, dyspnea, fatigue, anxiety and depression), the arrival of oxygen therapy in the home and the caregiver's social isolation.
Investigators believe that there are links and interactions between the caregiver's and patient's quality of life and therefore have an impact on the patient's care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient-caregiver dyads | – | Other: Caregiver Quality of Life Questionnaires, Other: Patient Quality of Life Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consultation at the Reference or Competence Centre for Rare Adult Lung Diseases
Key inclusion criteria (14 listed)
- Patient rescruited from prevalent cases and incidents of patients with IPF according to the diagnostic criteria of the 2011 ATS/ERS/JRS/ALAT recommendations, for which a follow-up is planned or is in progress
- Patient with a validated IPF diagnosis in multidisciplinary discussion in a Competence or Reference Centre. Regardless of the stage of the disease.
- Patient who has not opposed their enrollment in the study
- Adult patient
- Patient able to be assessed every 6 months by principal investigator
Key exclusion criteria (10 listed)
- Person subject to a measure of legal protection (curatorship, guardianship)
- Person with a legal guardian
- Adult unable to consent
- Psychiatric, cognitive or neurological disorders making assessment impossible
- Patient suffering from another medical condition considered severe by the investigator and which may interfere with the consequences of IVF (for example, active cancers, motor disability of neurological origin, osteo-articular diseases inducing dependence...)
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 |
|---|---|---|
| Caregiver Quality of Life QuestionnairesMeasurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score | Other | patient-caregiver dyads |
| Patient Quality of Life QuestionnairesQuality of life measurement at D0, M6 and M12 via the SF-36 | Other | patient-caregiver dyads |
Primary outcome
The generic quality of life score SF-36 to measure caregivers' quality of life
Time frame: Through study completion, an average of 12 months
Measurement of caregivers' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions of the component
The specific quality score CarGOQoL to measure caregivers' quality of life
Time frame: Through study completion, an average of 12 months
Measurement of caregivers' quality of life via the specific quality score CarGOQoL in each of the 10 dimensions of the component
2 secondary outcomes
"subjective burden" of caregivers
Time frame: Through study completion, an average of 12 months
Patients' Quality of life
Time frame: Through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Patient-caregiver Dyads, run by Centre Hospitalier Universitaire Dijon at 1 site 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The generic quality of life score SF-36 to measure caregivers' quality of life (time frame: Through study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2022.