Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients (HELP-IPF)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Dijon, Frankrijk
- CHU Dijon Bourgogne
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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...)
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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patient-caregiver dyads
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Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score
Quality of life measurement at D0, M6 and M12 via the SF-36
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The generic quality of life score SF-36 to measure caregivers' quality of life
Tijdsspanne: 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
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Through study completion, an average of 12 months
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The specific quality score CarGOQoL to measure caregivers' quality of life
Tijdsspanne: 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
|
Through study completion, an average of 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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"subjective burden" of caregivers
Tijdsspanne: Through study completion, an average of 12 months
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Measurement of the "subjective burden" of caregivers via the one-dimensional Zarit score
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Through study completion, an average of 12 months
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Patients' Quality of life
Tijdsspanne: Through study completion, an average of 12 months
|
Measurement of patients' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions
|
Through study completion, an average of 12 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BELTRAMO FRSR 2018
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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