Homecare Integral Support Program for IPF Patients
Not Applicable
Completed
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)
- Registration Number
- NCT05173571
- Lead Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nutritional and physical activity program Comprehensive patient support program (educational, physiotherapy, nutritional, emotional) Homecare IPF patient educational, nutritional and physical activity training based on patient's needs
- Primary Outcome Measures
Name Time Method Qulity of life 12 months K-BILD score (global and by domains)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IDIBELL. University Hospital of Bellvitge
🇪🇸Hospitalet de Llobregat, Spain