Homecare Integral Support Program for IPF Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

— PSPi-IPF  

Official title:

Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173571
• Other study ID #: PR118/18
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 12, 2021

Study information

• Verified date: December 2021
• Source: Institut d'Investigació Biomèdica de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 12, 2021
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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)

Locations

Country	Name	City	State
Spain	IDIBELL. University Hospital of Bellvitge	Hospitalet de Llobregat

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qulity of life	K-BILD score (global and by domains)	12 months