NCT02538289

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

August 31, 2015

Last Update Submit

February 23, 2017

Conditions

Dyspnea

Keywords

DyspneaPalliative CareHeart FailureChronic Pulmonary DiseaseOpioids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Detect the prevalence of dyspnea in patients admitted to our hospital.

    One month

  • Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.

    One month

  • Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.

    One year

  • Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.

    Three months

  • Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.

    One month

  • +3 more secondary outcomes

Study Arms (2)

Patients admitted before talks

OTHER

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

Behavioral: Teaching talks

Patients admitted after talks

OTHER

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

Behavioral: Teaching talks

Interventions

Teaching talksBEHAVIORAL

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 talksPatients admitted before talks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive Impairment
  • Voluntary dropout.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregorio Marañon University Hospital

Madrid, Madrid, 28007, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12570914BACKGROUND

MeSH Terms

Conditions

DyspneaHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Juan Manuel Nuñez Olarte, M.D.

    Hospital General Universitario Gregorio Marañon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Manuel Nuñez Olarte, M.D.

CONTACT

:+34 915868122jnunezo@salud.madrid.org

Manuel Martínez-Sellés

CONTACT

+34 915868286mmselles@secardiologia.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 2, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

February 24, 2017

Record last verified: 2016-02

Locations

ES(1)