Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

NCT ID: NCT02538289

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Dyspnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients admitted before talks

Patients admitted to Cardiology or Respiratory Medicine Departments before the interventional teaching talks.

Group Type OTHER

Teaching talks

Intervention Type BEHAVIORAL

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

Patients admitted after talks

Patients admitted to Cardiology or Respiratory Medicine Departments after the interventional teaching talks.

Group Type OTHER

Teaching talks

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Manuel Nuñez Olarte, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañon

Locations

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Gregorio Marañon University Hospital

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan Manuel Nuñez Olarte, M.D.

Role: CONTACT

:+34 915868122

Manuel Martínez-Sellés

Role: CONTACT

+34 915868286

Facility Contacts

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Manuel Martínez-Sellés, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12570914 (View on PubMed)

Other Identifiers

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Hospital without dyspnea

Identifier Type: -

Identifier Source: org_study_id

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