DyspneaNCT04015817
Interdisciplinary Approach for Refractory Dyspnoea
A study testing paramedical and non-pharmacological services in people with Dyspnea, run by Ligue Pulmonaire Neuchâteloise at 1 site in Switzerland.
Trial summary
Dyspnoea is a very common symptom in many diseases, not only cardiorespiratory, but also renal or neurological diseases. It can be defined as " difficult, laboured and uncomfortable breathing […]. It is a subjective symptom. As pain, it involves both the patient's perception of the sensation and his reaction to it ". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- paramedical and non-pharmacological services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2019to 1 Jun 2022
- 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
- refractory breathlessness on exertion or rest (Medical Research Council (MRC) dyspnea scale score ≥2), despite optimum treatment of the underlying disease, as deemed by the responsible physician;
- advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure, interstitial lung disease or motor neuron disease;
- willing to engage with proposed therapy (physiotherapy);
- able to provide informed consent in French.
Who cannot join
- Breathlessness of unknown cause;
- A primary diagnosis of chronic hyperventilation syndrome;
- Completely house (or hospital or nursing home) bound
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ligue pulmonaire neuchâteloise
Peseux, Canton of Neuchâtel, 2034
About this study
Official title: Impact of an Interdisciplinary Approach in the Management of Refractory Dyspnoea on Patients' Quality of Life by a Respiratory Care Team Non-specialized in Palliative Care
Dyspnoea is a very common symptom in many diseases, not only cardiorespiratory, but also renal or neurological diseases. It can be defined as " difficult, laboured and uncomfortable breathing […]. It is a subjective symptom. As pain, it involves both the patient's perception of the sensation and his reaction to it ". It can occur during even moderate effort and sometimes also at rest and tends to increase as the disease causing it progresses. Dyspnoea has therefore a significant on the various aspects of the patient's daily life and those around him or her (travel, leisure, daily activities, etc.) leading to a decrease in quality of life and possibly to anxiety and/or depressive symptoms. Among a vulnerable, elderly population that benefits from home care, it affects more than 46 % of patients in north-west of Switzerland.
Despite the handicap generated by daily dyspnoea, this complaint is often difficult to recognize by health professionals or family and friends, due in particular to a feeling of helplessness in the care provided. In addition, the treatment of the disease responsible for dyspnoea by the doctor does not always provide relief.
Read more
In this context, it is essential that people with dyspnoea, families and friends are supported in their experiences and acquire techniques and alternatives that help them better manage dyspnoea on a daily basis.
The first objective is to evaluate the feasibility of a dyspnoea support program led by a respiratory care team non-specialized in palliative care and its effect on quality of life and control of dyspnoea symptoms by patients .
A second objective is to measure patient's satisfaction about the program.
Read the detailed description
The dyspnoea support program will include 4 steps:
Step 1: Initial interview Before the initial interview, the responsible physician will review or examine the medical records via the request sheet sent by the referring physician or pneumologist containing the patient's diagnoses, history and medications. These files will then be sent to the team coordinator.
The team coordinator will meet the patient to obtain complete informations about his or her experiences with dyspnoea. Validated written questionnaires in French will be completed to complete the evaluation:
- Edmonton Symptom Assessment scale (ESAS):
- London Chest Activity of Daily Living (LCADL):
- Hospital Anxiety and Depression scale (HADS):
- Chronic Respiratory disease questionnaire (CRQ):
Blood oxygen saturation (Sp02) without O2 will be measured for each patient. If deemed necessary by the responsible physician (Dr. Clark) to complete the evaluation, a spirometry and an Incremental Shuttle Walk Test (ISWT) test will be performed by a physiotherapist.
Step 2: Specialized appointment:
The coordinator will review the patient to present the measures and strategies that will be proposed according to his/her needs and with reference to the evaluation carried out. An anti-dyspnoea checklist providing advice, useful information and exercises to better manage dyspnoea in daily living will be provided, as well as a self-observation logbook to optimize self-energy and fatigue management.
Step 3: Services:
The measures proposed by the coordinator and accepted by the patient will be implemented, for example: work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team, etc. As the measures proposed depend on the evaluation carried out, this is an individualised program. Different measures can be combined in various ways and successions to meet the needs of the patient.
Step 4: Assessment of progress:
Once the program is completed, evolution of dyspnoea perception following the program will be evaluated. CRQ and HADS questionnaires will be completed and patient's satisfaction will be evaluated (look "statistical consideration").
After the program, a follow-up is planned: patients will be seen again at 3 and 6 months after the program. It will then be a matter of completing the CRQ and HADS questionnaires and monitoring the patients' progress.
- Conditions
- Dyspnea
- Being tested
- paramedical and non-pharmacological services
- Keywords
- Dyspnea, Well being, respiratory care team non-specialized in palliative care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paramedical and non-pharmacological servicesOther
Paramedical and non-pharmacological services (work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team)
| Study group | Role | What they receive |
|---|---|---|
| Etude longitudinale | Experimental | Work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, support from the mobile palliative care team Receives: Other: paramedical and non-pharmacological services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change measured by the Chronic Respiratory Questionnaire (CRQ) between the initial interview (T0) and the progress report in patients with refractory dyspnea
Minimally important difference is reflected by a change in score of 0.5 on a 7 point scale
Measured: an average of four month
Secondary outcomes (1)
Measure patient satisfaction with the program in the progress report : visual analogic scale
Satisfaction assessment using a visual analogic scale (0-10)
Measured: an average of four month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Neuchâteloise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Fellrath, Prof, Principal investigator, Hopital Neuchatelois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015817
- Sponsor's protocol ID
- LPNE_02
- Status last verified
- Jun 2022
- First submitted
- 1 Jul 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share the data collected with other researchers.
Publications
Booth S, Burkin J, Moffat C, Spathis A. Managing Breathlessness in Clinical Practice. 1st ed. New York : Springer; 2013. 265 p.
Comroe, J. Some theories on the mechanism of dyspnea. In: Howell J, Campbell, E. Breathlessness: proceeding of an international symposium on breathlessness. Oxford: Blackwell; 1965.
Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
PubMed 25465642Clark, G, Marechal, M. COPD knowledge in a swiss frail selected population. European respiratory Society Congress 2018
Pautex S, Vayne-Bossert P, Bernard M, Beauverd M, Cantin B, Mazzocato C, Thollet C, Bollondi-Pauly C, Ducloux D, Herrmann F, Escher M. Validation of the French Version of the Edmonton Symptom Assessment System. J Pain Symptom Manage. 2017 Nov;54(5):721-726.e1. doi: 10.1016/j.jpainsymman.2017.07.032. Epub 2017 Jul 25.
PubMed 28751077Beaumont M, Couturaud F, Jego F, Pichon R, Le Ber C, Peran L, Roge C, Renault D, Narayan S, Reychler G. Validation of the French version of the London Chest Activity of Daily Living scale and the Dyspnea-12 questionnaire. Int J Chron Obstruct Pulmon Dis. 2018 Apr 30;13:1399-1405. doi: 10.2147/COPD.S145048. eCollection 2018.
PubMed 29750026Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
PubMed 25511175Bourbeau J, Maltais F, Rouleau M, Guimont C. French-Canadian version of the Chronic Respiratory and St George's Respiratory questionnaires: an assessment of their psychometric properties in patients with chronic obstructive pulmonary disease. Can Respir J. 2004 Oct;11(7):480-6. doi: 10.1155/2004/702421.
PubMed 15505701
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Interdisciplinary Approach in the Management of Refractory Dyspnoea on Patients' Quality of Life by a Respiratory Care Team Non-specialized in Palliative Care
- ClinicalTrials.gov ID
- NCT04015817
- Acronym / sponsor ID
- LPNE_02
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Well being, respiratory care team non-specialized in palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ligue Pulmonaire NeuchâteloiseUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jul 2019 (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.
Dyspnoea is a very common symptom in many diseases, not only cardiorespiratory, but also renal or neurological diseases. It can be defined as " difficult, laboured and uncomfortable breathing […]. It is a subjective symptom. As pain, it involves both the patient's perception of the sensation and his reaction to it ". It can occur during even moderate effort and sometimes also at rest and tends to increase as the disease causing it progresses. Dyspnoea has therefore a significant on the various aspects of the patient's daily life and those around him or her (travel, leisure, daily activities, etc.) leading to a decrease in quality of life and possibly to anxiety and/or depressive symptoms. Among a vulnerable, elderly population that benefits from home care, it affects more than 46 % of patients in north-west of Switzerland.
Despite the handicap generated by daily dyspnoea, this complaint is often difficult to recognize by health professionals or family and friends, due in particular to a feeling of helplessness in the care provided. In addition, the treatment of the disease responsible for dyspnoea by the doctor does not always provide relief.
In this context, it is essential that people with dyspnoea, families and friends are supported in their experiences and acquire techniques and alternatives that help them better manage dyspnoea on a daily basis.
The first objective is to evaluate the feasibility of a dyspnoea support program led by a respiratory care team non-specialized in palliative care and its effect on quality of life and control of dyspnoea symptoms by patients .
A second objective is to measure patient's satisfaction about the program.
Detailed description
The dyspnoea support program will include 4 steps:
Step 1: Initial interview Before the initial interview, the responsible physician will review or examine the medical records via the request sheet sent by the referring physician or pneumologist containing the patient's diagnoses, history and medications. These files will then be sent to the team coordinator.
The team coordinator will meet the patient to obtain complete informations about his or her experiences with dyspnoea. Validated written questionnaires in French will be completed to complete the evaluation:
- Edmonton Symptom Assessment scale (ESAS):
- London Chest Activity of Daily Living (LCADL):
- Hospital Anxiety and Depression scale (HADS):
- Chronic Respiratory disease questionnaire (CRQ):
Blood oxygen saturation (Sp02) without O2 will be measured for each patient. If deemed necessary by the responsible physician (Dr. Clark) to complete the evaluation, a spirometry and an Incremental Shuttle Walk Test (ISWT) test will be performed by a physiotherapist.
Step 2: Specialized appointment:
The coordinator will review the patient to present the measures and strategies that will be proposed according to his/her needs and with reference to the evaluation carried out. An anti-dyspnoea checklist providing advice, useful information and exercises to better manage dyspnoea in daily living will be provided, as well as a self-observation logbook to optimize self-energy and fatigue management.
Step 3: Services:
The measures proposed by the coordinator and accepted by the patient will be implemented, for example: work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team, etc. As the measures proposed depend on the evaluation carried out, this is an individualised program. Different measures can be combined in various ways and successions to meet the needs of the patient.
Step 4: Assessment of progress:
Once the program is completed, evolution of dyspnoea perception following the program will be evaluated. CRQ and HADS questionnaires will be completed and patient's satisfaction will be evaluated (look "statistical consideration").
After the program, a follow-up is planned: patients will be seen again at 3 and 6 months after the program. It will then be a matter of completing the CRQ and HADS questionnaires and monitoring the patients' progress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etude longitudinale | Experimental | Other: paramedical and non-pharmacological servicesWork on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, support from the mobile palliative care team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- refractory breathlessness on exertion or rest (Medical Research Council (MRC) dyspnea scale score ≥2), despite optimum treatment of the underlying disease, as deemed by the responsible physician;
- advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure, interstitial lung disease or motor neuron disease;
- willing to engage with proposed therapy (physiotherapy);
- able to provide informed consent in French.
Key exclusion criteria (3 listed)
- Breathlessness of unknown cause;
- A primary diagnosis of chronic hyperventilation syndrome;
- Completely house (or hospital or nursing home) bound
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 |
|---|---|---|
| paramedical and non-pharmacological servicesParamedical and non-pharmacological services (work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team) | Other | Etude longitudinale |
Primary outcome
Change measured by the Chronic Respiratory Questionnaire (CRQ) between the initial interview (T0) and the progress report in patients with refractory dyspnea
Time frame: an average of four month
Minimally important difference is reflected by a change in score of 0.5 on a 7 point scale
1 secondary outcome
Measure patient satisfaction with the program in the progress report : visual analogic scale
Time frame: an average of four month
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 6 Jul 2022.
- BackgroundBooth S, Burkin J, Moffat C, Spathis A. Managing Breathlessness in Clinical Practice. 1st ed. New York : Springer; 2013. 265 p.
- BackgroundComroe, J. Some theories on the mechanism of dyspnea. In: Howell J, Campbell, E. Breathlessness: proceeding of an international symposium on breathlessness. Oxford: Blackwell; 1965.
- Background: PubMed 25465642Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.
- BackgroundClark, G, Marechal, M. COPD knowledge in a swiss frail selected population. European respiratory Society Congress 2018
- Background: PubMed 28751077Pautex S, Vayne-Bossert P, Bernard M, Beauverd M, Cantin B, Mazzocato C, Thollet C, Bollondi-Pauly C, Ducloux D, Herrmann F, Escher M. Validation of the French Version of the Edmonton Symptom Assessment System. J Pain Symptom Manage. 2017 Nov;54(5):721-726.e1. doi: 10.1016/j.jpainsymman.2017.07.032. Epub 2017 Jul 25.
- Background: PubMed 29750026Beaumont M, Couturaud F, Jego F, Pichon R, Le Ber C, Peran L, Roge C, Renault D, Narayan S, Reychler G. Validation of the French version of the London Chest Activity of Daily Living scale and the Dyspnea-12 questionnaire. Int J Chron Obstruct Pulmon Dis. 2018 Apr 30;13:1399-1405. doi: 10.2147/COPD.S145048. eCollection 2018.
- Background: PubMed 25511175Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
- Background: PubMed 15505701Bourbeau J, Maltais F, Rouleau M, Guimont C. French-Canadian version of the Chronic Respiratory and St George's Respiratory questionnaires: an assessment of their psychometric properties in patients with chronic obstructive pulmonary disease. Can Respir J. 2004 Oct;11(7):480-6. doi: 10.1155/2004/702421.
- Individual participant dataSharing planned: No. There are no plans to share the data collected with other researchers.
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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.
Jean-Marc Fellrath, Prof principal investigator
Hopital Neuchatelois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paramedical and non-pharmacological services in people with Dyspnea, run by Ligue Pulmonaire Neuchâteloise at 1 site in Switzerland.
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 4 inclusion and 3 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 6 Jul 2022. 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 Switzerland. 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?
Change measured by the Chronic Respiratory Questionnaire (CRQ) between the initial interview (T0) and the progress report in patients with refractory dyspnea (time frame: an average of four month). 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 NCT04015817, which also lists 8 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 6 Jul 2022.