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Trial record 1 of 1 for:    NCT04031690
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Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients (HELP-IPF)

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ClinicalTrials.gov Identifier: NCT04031690
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.

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.


Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Patient-caregiver Dyads Other: Caregiver Quality of Life Questionnaires Other: Patient Quality of Life Questionnaires

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022


Group/Cohort Intervention/treatment
patient-caregiver dyads Other: Caregiver Quality of Life Questionnaires
Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score

Other: Patient Quality of Life Questionnaires
Quality of life measurement at D0, M6 and M12 via the SF-36




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. "subjective burden" of caregivers [ Time Frame: Through study completion, an average of 12 months ]
    Measurement of the "subjective burden" of caregivers via the one-dimensional Zarit score

  2. Patients' Quality of life [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consultation at the Reference or Competence Centre for Rare Adult Lung Diseases
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031690


Contacts
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Contact: Guillaume BELTRAMO 03.80.29.37.72 guillaume.beltramo@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France
Contact: Guillaumd BELTRAMO    03.80.29.37.72 ext +33    guillaume.beltramo@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04031690    
Other Study ID Numbers: BELTRAMO FRSR 2018
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial