免费获得国外相关药品，最快 1 个工作日回馈药物信息
Interdisciplinary Approach for Refractory Dyspnoea
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dyspnea | Other: paramedical and non-pharmacological services | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Estimated Study Start Date : | August 2019 |
| Estimated Primary Completion Date : | February 2021 |
| Estimated Study Completion Date : | April 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Etude longitudinale
Work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, support from the mobile palliative care team
|
Other: paramedical and non-pharmacological services
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)
|
- 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
- Measure patient satisfaction with the program in the progress report : visual analogic scale [ Time Frame: an average of four month ]Satisfaction assessment using a visual analogic scale (0-10)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Breathlessness of unknown cause;
- A primary diagnosis of chronic hyperventilation syndrome;
- Completely house (or hospital or nursing home) bound
| Contact: Gregory Clark, Dr | 079 281 53 28 | gclark@clarkpneumo.ch | |
| Contact: Marc Marechal | 0327202050 | marc.marechal@lpne.ch |
| Principal Investigator: | Jean-Marc Fellrath, Prof | Hopital Neuchatelois |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 1, 2019 | ||||||||
| First Posted Date ICMJE | July 11, 2019 | ||||||||
| Last Update Posted Date | July 11, 2019 | ||||||||
| Estimated Study Start Date ICMJE | August 2019 | ||||||||
| Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Measure patient satisfaction with the program in the progress report : visual analogic scale [ Time Frame: an average of four month ] Satisfaction assessment using a visual analogic scale (0-10)
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Interdisciplinary Approach for Refractory Dyspnoea | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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 ". 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:
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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Dyspnea | ||||||||
| Intervention ICMJE | Other: paramedical and non-pharmacological services
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 Arms ICMJE | Experimental: Etude longitudinale
Work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, support from the mobile palliative care team
Intervention: Other: paramedical and non-pharmacological services
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 2021 | ||||||||
| Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04015817 | ||||||||
| Other Study ID Numbers ICMJE | LPNE_02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Ligue Pulmonaire Neuchâteloise | ||||||||
| Study Sponsor ICMJE | Ligue Pulmonaire Neuchâteloise | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Ligue Pulmonaire Neuchâteloise | ||||||||
| Verification Date | July 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
