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Homecare Integral Support Program for IPF Patients

NCT ID: NCT05173571

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-12-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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Homecare patient support

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Minimal intervention study, pre- and post- supportive care effects on quality of life
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutritional and physical activity program

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

Group Type EXPERIMENTAL

Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)

Intervention Type COMBINATION_PRODUCT

Identification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist)

Interventions

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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)

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Nurse and Respiratory Physiotherapist holistic plan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Maria Molina

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IDIBELL. University Hospital of Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PR118/18

Identifier Type: -

Identifier Source: org_study_id