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Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02538289
Enrollment
100
Registered
2015-09-02
Start date
2016-04-30
Completion date
2017-12-31
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea

Keywords

Dyspnea, Palliative Care, Heart Failure, Chronic Pulmonary Disease, Opioids

Brief 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. 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.

Interventions

BEHAVIORALTeaching talks

Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Cognitive Impairment * Voluntary dropout.

Design outcomes

Primary

MeasureTime frameDescription
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.One monthDecrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.

Secondary

MeasureTime frameDescription
Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.One monthFrequency of methods usage for dyspnea relief.
Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.One yearNumerical Rating Scale score.
Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.Three monthsNumber of patients that receive opioid treatment at three months of inclusion
Detect the prevalence of dyspnea in patients admitted to our hospital.One monthNumber of patients.
Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.Three monthsDyspnea intensity by Numerical Rating Scale score
Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.Three monthsNumber of patients that present side effects
Determine whether a specific educational talk would be affordable for dyspnea managementOne monthCosts in euros invested in medical staff training
Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.One monthDyspnea intensity by Numerical Rating Scale score

Countries

Spain

Contacts

Primary ContactJuan Manuel Nuñez Olarte, M.D.
jnunezo@salud.madrid.org:+34 915868122
Backup ContactManuel Martínez-Sellés
mmselles@secardiologia.es+34 915868286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026