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Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients (HELP-IPF)

14. april 2022 opdateret af: Centre Hospitalier Universitaire Dijon

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

151

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Dijon, Frankrig
        • CHU Dijon Bourgogne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Consultation at the Reference or Competence Centre for Rare Adult Lung Diseases

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
patient-caregiver dyads
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The generic quality of life score SF-36 to measure caregivers' quality of life
Tidsramme: 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
Through study completion, an average of 12 months
The specific quality score CarGOQoL to measure caregivers' quality of life
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
"subjective burden" of caregivers
Tidsramme: Through study completion, an average of 12 months
Measurement of the "subjective burden" of caregivers via the one-dimensional Zarit score
Through study completion, an average of 12 months
Patients' Quality of life
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. oktober 2019

Primær færdiggørelse (Faktiske)

28. september 2020

Studieafslutning (Faktiske)

15. december 2021

Datoer for studieregistrering

Først indsendt

22. juli 2019

Først indsendt, der opfyldte QC-kriterier

23. juli 2019

Først opslået (Faktiske)

24. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BELTRAMO FRSR 2018

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Idiopatisk lungefibrose

Kliniske forsøg med Caregiver Quality of Life Questionnaires

Abonner