Homecare Integral Support Program for IPF Patients (PSPi-IPF)

Institut d'Investigació Biomèdica de Bellvitge

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)

Study type: Interventional

Funder types: Other

Identifiers

NCT05173571

PR118/18

Details and patient eligibility

About

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

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Nutritional and physical activity program

Experimental group

Description:

Homecare IPF patient educational, nutritional and physical activity training based on patient's needs

Treatment:

Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)