Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Dyspnea Clinical Trial

Official title:

Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02538289
• Other study ID #: Hospital without dyspnea
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: February 23, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Juan Manuel Nuñez Olarte, M.D.
• Phone: :+34 915868122
• Email: jnunezo[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Although there are several tools that may produce an improvement of symptom intensity, they are underused.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspnea

Intervention

Behavioral:
• Teaching 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.

Locations

Country	Name	City	State
Spain	Gregorio Marañon University Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Badia X, Muriel C, Gracia A, Núñez-Olarte JM, Perulero N, Gálvez 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. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One month
Secondary	Detect the prevalence of dyspnea in patients admitted to our hospital.	Number of patients.	One month
Secondary	Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.	Frequency of methods usage for dyspnea relief.	One month
Secondary	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.	One year
Secondary	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	Three months
Secondary	Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.	Dyspnea intensity by Numerical Rating Scale score	One month
Secondary	Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.	Dyspnea intensity by Numerical Rating Scale score	Three months
Secondary	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	Three months
Secondary	Determine whether a specific educational talk would be affordable for dyspnea management	Costs in euros invested in medical staff training	One month