Homecare Integral Support Program for IPF Patients

NCT05173571 | Completed DMC

• 1 other identifier: PR118/18
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Homecare patient support

Outcome Measures

Primary Outcomes (1)

• Qulity of life

  K-BILD score (global and by domains)

  12 months

Study Arms (1)

Nutritional and physical activity program

EXPERIMENTAL

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

Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)

Interventions

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

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

Also known as: Nurse and Respiratory Physiotherapist holistic plan

Nutritional and physical activity program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead

Study Sites (1)

IDIBELL. University Hospital of Bellvitge

L'Hospitalet de Llobregat, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Physical Therapy Modalities; Nurses

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Minimal intervention study, pre- and post- supportive care effects on quality of life

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: December 30, 2021
• Study Start: July 1, 2018
• Primary Completion: April 20, 2020
• Study Completion: December 12, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

ES (1)