Idiopathic Pulmonary FibrosisPSPi-IPFNCT05173571
Homecare Integral Support Program for IPF Patients
A study testing Comprehensive patient support program (educational, physiotherapy, nutritional, emotional) in people with Idiopathic Pulmonary Fibrosis, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.
Trial summary
Homecare patient support program especially designed for covering IPF patient needs, implemented for 12 months, for improving quality of life Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)
- Keywords
- Homecare patient support
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)Combination product
Also called Nurse and Respiratory Physiotherapist holistic plan
Identification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist)
| Study group | Role | What they receive |
|---|---|---|
| Nutritional and physical activity program | Experimental | Homecare IPF patient educational, nutritional and physical activity training based on patient's needs Receives: Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qulity of life
K-BILD score (global and by domains)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jul 2018
- Primary completion20 Apr 2020
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Minimal intervention study, pre- and post- supportive care effects on quality of life
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Molina, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173571
- Sponsor's protocol ID
- PR118/18
- Acronym
- PSPi-IPF
- Status last verified
- Dec 2021
- First submitted
- 27 Oct 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05173571
- Acronym / sponsor ID
- PSPi-IPF / PR118/18
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Homecare patient support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Minimal intervention study, pre- and post- supportive care effects on quality of life
| Arm | Type | Receives |
|---|---|---|
| Nutritional and physical activity program | Experimental | Combination Product: Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)Homecare IPF patient educational, nutritional and physical activity training based on patient's needs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive patient support program (educational, physiotherapy, nutritional, emotional)Also: Nurse and Respiratory Physiotherapist holistic planIdentification of patient needs and non-pharmacological holistic approach, including education, emotion and nutrition (nurse) and optimization of physical activity (respiratory physiotherapist) | Combination product | Nutritional and physical activity program |
Primary outcome
Qulity of life
Time frame: 12 months
K-BILD score (global and by domains)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive patient support program (educational, physiotherapy, nutritional, emotional) in people with Idiopathic Pulmonary Fibrosis, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qulity of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.