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

December 12, 2021 updated by: Maria Molina, Institut d'Investigació Biomèdica de Bellvitge

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
K-BILD score (global and by domains)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigació Biomèdica de Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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