Homecare Integral Support Program for IPF Patients

Study Overview
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Brief Summary
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Homecare patient support program especially designed for covering IPF patient needs, implemented for 12 months, for improving quality of life

Detailed Description
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The proposed comprehensive IPF home care programme consists of: 1) improving patient's quality of life (autonomy, activity, emotional well-being and symptoms), 2) reducing the number and severity of side effects associated with the anti-fibrotic drug, 3) reducing the number of hospitalisations attributable to the disease, and 4) providing a rapid response to any problem associated with the disease (after diagnosis or progression) that may cause distress or require early action.

Official Title
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Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IPF patients with FVC > 50% and DLCO > 30%, in whom pharmacological treatment with nintedanib was started at least one month before the start of the programme. Exclusion Criteria: Hospitalised patients or those who have been hospitalised in the previous month, due to any kind of respiratory exacerbation or due to any other respiratory cause. Patients who are under home care controls (PADES) as this implies an advanced stage of the disease (forced vital capacity [FVC] less than 50% and the diffusion capacity of the lungs for carbon monoxide [DLCO] less than 30%) or, patients thathave a lack of autonomy due to comorbidities or respiratory failure Patients diagnosed in incipient phase who have neither symptoms nor limitation in their usual activities. Patients who have suffered any other life-threatening disease in the last 2 years, such as cancer or uncontrolled ischaemic heart disease. Inability to understand the information given to the patient, relating to the legal aspects of the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Minimal intervention study, pre- and post- supportive care effects on quality of life
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional and physical activity program<br>Homecare IPF patient educational, nutritional and physical activity training based on patient's needs | Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)<br>* Identification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist)<br>* Other names: Nurse and Respiratory Physiotherapist holistic plan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qulity of life | K-BILD score (global and by domains) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homecare patient support