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

Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Combination product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Hospitalet de Llobregat, Spain
    • IDIBELL. University Hospital of Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: December 12, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Homecare patient support
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: PR118/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No