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NCT Number: NCT04031690

Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Patient-caregiver Dyads Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caregiver Quality of Life Questionnaires

Other

Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score

Patient Quality of Life Questionnaires

Other

Quality of life measurement at D0, M6 and M12 via the SF-36

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: HELP-IPF

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 24, 2019
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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