COPDPIMAOXNCT04691336
Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
A study testing Educational and Training with counselling in people with COPD and ILD, run by Air Liquide Healthcare Spain at 1 site in Spain.
Trial summary
Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Educational and Training with counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 30 Sep 2019
- 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
- Adult patients (over 18 years old) with prescription of portable oxygen therapy by the Pneumology Service of the Sant Joan de Dèu Hospital in Manresa.
Who cannot join
- Psychophysical inability to carry out questionnaires or refusal to answer them.
- Severe displacement problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piloto Study of an Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.
Read the detailed description
All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.
- Being tested
- Educational and Training with counselling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and Training with counsellingBehavioural
The nurse conducts a structured interview that covers the following areas: information on respiratory attraction and the symptom of dyspnea, expectations and beliefs about oxygen therapy, use of oxygen therapy, healthy habits, social support. It also evaluates the patient's perception of oxygen therapy, and the level of dyspnea using the mMRC scale. After this, the nurse evaluates the current level of adherence, and if she considers that the patient needs a reinforcement session, she schedules a workshop with 3 other patients and their main caregivers. This workshop takes place 30 days after this interview. In other patients, depending on the level of adherence, a support call is made, and all patients are visited again at the center at 90 days, performing the same evaluation with a structured interview and the scales that were made on day 1
| Study group | Role | What they receive |
|---|---|---|
| PIMAGroup | Experimental | All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc. Receives: Behavioral: Educational and Training with counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence - Changes
Number of hours of use of oxygen concentrator / day
Measured: Day 1 and Day 90
Dyspnea - Changes
Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.
Measured: Day 1 and Day 90
Quality of Life - Changes
General well-being state, measured with a visual analog scale. Minimum score: 0, Maximum score: 10. A high score implies a better outcome.
Measured: Day 1 and Day 90
Emotional State - Changes
Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Measured: Day 1 and Day 90
Activities
Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Measured: Day 1 and Day 90
Social Relations
Level of social activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Measured: Day 1 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Mar 2019
- Primary completion26 Apr 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Healthcare Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Principal investigator, David Rudilla, Air Liquide Healthcare Spain
- Investigators
- David Rudilla, PhD, Principal investigator, Air Liquide Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691336
- Sponsor's protocol ID
- PIMAOX-CEI 20/04
- Acronym
- PIMAOX
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Clinical impact, assistance and / or technological development. This project has a great impact and clinical and technological significance. From the clinical point of view, the aim is to identify the patient in order to better serve him and ensure adherence to one of the treatments where it is more complex to achieve patient compliance. 2. Bibliometric impact. This project is expected to lead to world-class, high-impact publications.
Publications
Rudilla D, Valenzuela C, Beceiro MJ, Alonso T, Ancochea J. Fibrosis pulmonar idiopática y emociones. Una revisión sobre los aspectos psicológicos de la enfermedad. Rev Patol Respir. 2018; 21(2): 54-60
Rudilla D, Oliver A, Galiana L, Barreto P. A new measure of home care patients' dignity at the end of life: The Palliative Patients' Dignity Scale (PPDS). Palliat Support Care. 2016 Apr;14(2):99-108. doi: 10.1017/S1478951515000747. Epub 2015 Jun 11.
PubMed 26062752
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloto Study of an Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
- ClinicalTrials.gov ID
- NCT04691336
- Acronym / sponsor ID
- PIMAOX / PIMAOX-CEI 20/04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Air Liquide Healthcare SpainIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Dec 2020 (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.
Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.
Detailed description
All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIMAGroup | Experimental | Behavioral: Educational and Training with counsellingAll patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (over 18 years old) with prescription of portable oxygen therapy by the Pneumology Service of the Sant Joan de Dèu Hospital in Manresa.
Key exclusion criteria (2 listed)
- Psychophysical inability to carry out questionnaires or refusal to answer them.
- Severe displacement problems.
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 |
|---|---|---|
| Educational and Training with counsellingThe nurse conducts a structured interview that covers the following areas: information on respiratory attraction and the symptom of dyspnea, expectations and beliefs about oxygen therapy, use of oxygen therapy, healthy habits, social support. It also evaluates the patient's perception of oxygen therapy, and the level of dyspnea using the mMRC scale. After this, the nurse evaluates the current level of adherence, and if she considers that the patient needs a reinforcement session, she schedules a workshop with 3 other patients and their main caregivers. This workshop takes place 30 days after this interview. In other patients, depending on the level of adherence, a support call is made, and all patients are visited again at the center at 90 days, performing the same evaluation with a structured interview and the scales that were made on day 1 | Behavioural | PIMAGroup |
Primary outcome
Adherence - Changes
Time frame: Day 1 and Day 90
Number of hours of use of oxygen concentrator / day
Dyspnea - Changes
Time frame: Day 1 and Day 90
Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.
Quality of Life - Changes
Time frame: Day 1 and Day 90
General well-being state, measured with a visual analog scale. Minimum score: 0, Maximum score: 10. A high score implies a better outcome.
Emotional State - Changes
Time frame: Day 1 and Day 90
Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Activities
Time frame: Day 1 and Day 90
Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Social Relations
Time frame: Day 1 and Day 90
Level of social activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
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 31 Dec 2020.
- BackgroundRudilla D, Valenzuela C, Beceiro MJ, Alonso T, Ancochea J. Fibrosis pulmonar idiopática y emociones. Una revisión sobre los aspectos psicológicos de la enfermedad. Rev Patol Respir. 2018; 21(2): 54-60
- Background: PubMed 26062752Rudilla D, Oliver A, Galiana L, Barreto P. A new measure of home care patients' dignity at the end of life: The Palliative Patients' Dignity Scale (PPDS). Palliat Support Care. 2016 Apr;14(2):99-108. doi: 10.1017/S1478951515000747. Epub 2015 Jun 11.
- Individual participant dataSharing planned: Yes. 1. Clinical impact, assistance and / or technological development. This project has a great impact and clinical and technological significance. From the clinical point of view, the aim is to identify the patient in order to better serve him and ensure adherence to one of the treatments where it is more complex to achieve patient compliance. 2. Bibliometric impact. This project is expected to lead to world-class, high-impact publications.
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
David Rudilla, PhD principal investigator
Air Liquide Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and Training with counselling in people with COPD and ILD, run by Air Liquide Healthcare Spain 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 2 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 31 Dec 2020. 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?
Adherence - Changes (time frame: Day 1 and Day 90). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691336, which also lists 2 linked publications.
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 31 Dec 2020.