DyspneaNCT02538289
Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention
A study testing Teaching talks in people with Dyspnea, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Teaching talks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Dec 2017
- 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
- Hospital admission with dyspnea as main symptom
- Acceptance of participation in the study
- Diagnosis of Chronic Respiratory Disease
- Diagnosis of Chronic Heart Failure
- Chronic Refractory Dyspnea higher than 1/10 and Irruptive Dyspnea higher than 2/10 degree by Rating Numerical Scale
Who cannot join
- Cognitive Impairment
- Voluntary dropout.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Gregorio Marañon University Hospital
Madrid, Madrid, 28007
Manuel Martínez-Sellés, MD
About this study
Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools that may produce an improvement of symptom intensity, they are underused.
Read the detailed description
We sought to investigate whether if teaching interventions specifically addressed to medical staff improve the well-being of dyspneic patients. The MAIN GOAL of this study is to evaluate the effect of two talks (conveyed to doctors and nurses of Cardiology and Respiratory Medicine Departments) on the patient-perceived dyspnea. The contents of these talks will be prepared and supervised by Palliative Care specialists.
This is a four-staged study that includes a first observational phase (prevalence study of dyspnea) followed by intervention and a third phase that will determine the effect of this teaching intervention. The fourth phase consists in the elaboration of specific protocols for management of dyspnea.
A pharmacovigilance study of opioids will also take place.
- Conditions
- Dyspnea
- Being tested
- Teaching talks
- Keywords
- Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching talksBehavioural
Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted before talks | Other | Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks. Receives: Behavioral: Teaching talks |
| Patients admitted after talks | Other | Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks. Receives: Behavioral: Teaching talks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment.
Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.
Measured: One month
Secondary outcomes (8)
Detect the prevalence of dyspnea in patients admitted to our hospital.
Number of patients.
Measured: One month
Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
Frequency of methods usage for dyspnea relief.
Measured: One month
Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.
Numerical Rating Scale score.
Measured: One year
Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Number of patients that receive opioid treatment at three months of inclusion
Measured: Three months
Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.
Dyspnea intensity by Numerical Rating Scale score
Measured: One month
Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Dyspnea intensity by Numerical Rating Scale score
Measured: Three months
Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.
Number of patients that present side effects
Measured: Three months
Determine whether a specific educational talk would be affordable for dyspnea management
Costs in euros invested in medical staff training
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startApr 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Juan Manuel Nuñez Olarte, M.D., Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538289
- Sponsor's protocol ID
- Hospital without dyspnea
- Status last verified
- Feb 2016
- First submitted
- 31 Aug 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Badia X, Muriel C, Gracia A, Nunez-Olarte JM, Perulero N, Galvez R, Carulla J, Cleeland CS; Grupo Vesbpi. [Validation of the Spanish version of the Brief Pain Inventory in patients with oncological pain]. Med Clin (Barc). 2003 Jan 25;120(2):52-9. doi: 10.1016/s0025-7753(03)73601-x. Spanish.
PubMed 12570914
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention
- ClinicalTrials.gov ID
- NCT02538289
- Acronym / sponsor ID
- Hospital without dyspnea
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Sep 2015 (estimated)
- 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.
Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools that may produce an improvement of symptom intensity, they are underused.
Detailed description
We sought to investigate whether if teaching interventions specifically addressed to medical staff improve the well-being of dyspneic patients. The MAIN GOAL of this study is to evaluate the effect of two talks (conveyed to doctors and nurses of Cardiology and Respiratory Medicine Departments) on the patient-perceived dyspnea. The contents of these talks will be prepared and supervised by Palliative Care specialists.
This is a four-staged study that includes a first observational phase (prevalence study of dyspnea) followed by intervention and a third phase that will determine the effect of this teaching intervention. The fourth phase consists in the elaboration of specific protocols for management of dyspnea.
A pharmacovigilance study of opioids will also take place.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients admitted before talks | Other | Behavioral: Teaching talksPatients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks. |
| Patients admitted after talks | Other | Behavioral: Teaching talksPatients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospital admission with dyspnea as main symptom
- Acceptance of participation in the study
- Diagnosis of Chronic Respiratory Disease
- Diagnosis of Chronic Heart Failure
- Chronic Refractory Dyspnea higher than 1/10 and Irruptive Dyspnea higher than 2/10 degree by Rating Numerical Scale
Key exclusion criteria (2 listed)
- Cognitive Impairment
- Voluntary dropout.
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 |
|---|---|---|
| Teaching talksTwo teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment. | Behavioural | Patients admitted after talks, Patients admitted before talks |
Primary outcome
Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment.
Time frame: One month
Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.
8 secondary outcomes
Detect the prevalence of dyspnea in patients admitted to our hospital.
Time frame: One month
Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
Time frame: One month
Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.
Time frame: One year
Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Time frame: Three months
Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.
Time frame: One month
Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Time frame: Three months
Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.
Time frame: Three months
Determine whether a specific educational talk would be affordable for dyspnea management
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Background: PubMed 12570914Badia X, Muriel C, Gracia A, Nunez-Olarte JM, Perulero N, Galvez R, Carulla J, Cleeland CS; Grupo Vesbpi. [Validation of the Spanish version of the Brief Pain Inventory in patients with oncological pain]. Med Clin (Barc). 2003 Jan 25;120(2):52-9. doi: 10.1016/s0025-7753(03)73601-x. Spanish.
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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.
Juan Manuel Nuñez Olarte, M.D. principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching talks in people with Dyspnea, run by Hospital General Universitario Gregorio Marañon 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 5 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: status not confirmed, as of the sponsor's last update on 24 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Manuel Nuñez Olarte, M.D. (:+34 915868122, jnunezo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment. (time frame: One 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 NCT02538289, which also lists 1 linked publication.
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 24 Feb 2017.