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
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
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
- 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
- "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
- 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
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
|Contact: Guillaume BELTRAMOemail@example.com|
|CHU Dijon Bourgogne||Recruiting|
|Contact: Guillaumd BELTRAMO 03.80.29.37.72 ext +33 firstname.lastname@example.org|