Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

February 23, 2017 updated by: Hospital General Universitario Gregorio Marañon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Gregorio Maranon University Hospital
        • Contact:
          • Manuel Martínez-Sellés, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients admitted before talks
Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.
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.
Other: Patients admitted after talks
Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect the prevalence of dyspnea in patients admitted to our hospital.
Time Frame: One month
Number of patients.
One month
Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.
Time Frame: One month
Frequency of methods usage for dyspnea relief.
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
Numerical Rating Scale score.
One year
Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Time Frame: Three months
Number of patients that receive opioid treatment at three months of inclusion
Three months
Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.
Time Frame: One month
Dyspnea intensity by Numerical Rating Scale score
One month
Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.
Time Frame: Three months
Dyspnea intensity by Numerical Rating Scale score
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
Number of patients that present side effects
Three months
Determine whether a specific educational talk would be affordable for dyspnea management
Time Frame: One month
Costs in euros invested in medical staff training
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Juan Manuel Nuñez Olarte, M.D., Hospital General Universitario Gregorio Maranon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital without dyspnea

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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