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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)
Sponsored by
Institut d'Investigació Biomèdica de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Idiopathic Pulmonary Fibrosis focused on measuring Homecare patient support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IDIBELL. University Hospital of Bellvitge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional and physical activity program

Arm Description

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

Outcomes

Primary Outcome Measures

Qulity of life
K-BILD score (global and by domains)

Secondary Outcome Measures

Full Information

First Posted
October 27, 2020
Last Updated
December 12, 2021
Sponsor
Institut d'Investigació Biomèdica de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT05173571
Brief Title
Homecare Integral Support Program for IPF Patients
Acronym
PSPi-IPF
Official Title
Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Homecare patient support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Minimal intervention study, pre- and post- supportive care effects on quality of life
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional and physical activity program
Arm Type
Experimental
Arm Description
Homecare IPF patient educational, nutritional and physical activity training based on patient's needs
Intervention Type
Combination Product
Intervention Name(s)
Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)
Other Intervention Name(s)
Nurse and Respiratory Physiotherapist holistic plan
Intervention Description
Identification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist)
Primary Outcome Measure Information:
Title
Qulity of life
Description
K-BILD score (global and by domains)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IDIBELL. University Hospital of Bellvitge
City
Hospitalet de Llobregat
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Homecare Integral Support Program for IPF Patients

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